In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device<\/a> \u2014 \u201ca Class I recall, the most serious type,\u201d the FDA said.<\/p>\n

\u201cUse of this device may cause serious injuries or death,\u201d an FDA notice<\/a> about the recall said.<\/p>\n

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.<\/p>\n

In a notice<\/a>, the manufacturer explained, \u201cAbbott is not removing product from commercial distribution.\u201d Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.<\/p>\n

When it comes to medical devices, recalls can include not only \u201cremovals,\u201d in which the device is removed from where it is used or sold, but also \u201ccorrections,\u201d which address the problem in the field \u2014 for instance, by repairing, adjusting, relabeling, or inspecting a device.<\/p>\n

\u201cIt\u2019s very oxymoronic,\u201d said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. \u201cA recall makes it sound like it\u2019s recalled. But that is not actually what it means.\u201d<\/p>\n

Though the FDA and federal regulations<\/a> call these actions recalls<\/a>, they might be described more aptly as \u201c non-recalls<\/a>.\u201d And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices<\/a>, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.<\/p>\n

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Safeguarding the Public<\/strong><\/p>\n
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?<\/p>\n
There are other ways to handle recalls. In announcements about products<\/a> as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars<\/a> back to the dealer to have them fixed. When the U.S. Department of Agriculture<\/a> and the FDA announce food recalls<\/a>, they routinely tell consumers to return or discard<\/a> the food.<\/p>\n
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don\u2019t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.<\/p>\n
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.<\/p>\n
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.<\/p>\n
\u201cWhen deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,\u201d FDA spokesperson Audra Harrison said.<\/p>\n
Where recalled devices have already been implanted, \u201cremoval\u201d doesn\u2019t necessarily mean removing them from patients\u2019 bodies. \u201cWhen an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,\u201d the FDA website says.<\/p>\n
The FDA allowed the recalled MitraClip devices to remain in use \u201cbecause the agency believed that the overall benefits of the device continued to outweigh the risks and the firm\u2019s recall strategy was appropriate and adequate,\u201d Harrison said.<\/p>\n
The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.<\/p>\n
Abbott, the maker of MitraClip, said the device has been proven safe and effective \u201cbased on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,\u201d a condition in which blood flows backward through the heart\u2019s mitral valve. The condition can lead to heart failure and death.<\/p>\n
\u201cWith MitraClip, we\u2019re addressing the needs of people with MR who often have no other options,\u201d company spokesperson Brent Tippen said.<\/p>\n
Speaking of the MitraClip recalls, Redberg said, \u201cSo hard to imagine these are effective actions in protecting patients.\u201d<\/p>\n
In 2021, for Medtronic\u2019s StealthStation S7 cranial software, the company and the FDA sent a different message.<\/p>\n
StealthStation is an elaborate system<\/a> of screens and other equipment<\/a> that guides neurosurgeons using instruments in the brain \u2014 for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it\u2019s meant to show the location of the surgical instruments.<\/p>\n
In connection with a Class I November 2021 recall<\/a>, the FDA website said potential inaccuracies in a biopsy depth gauge could result in \u201clife-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.\u201d<\/p>\n
The FDA website explained what Medtronic was doing about it.<\/p>\n
\u201cThe recalling firm will provide a warning and instructional placard<\/a> to be applied to impacted systems,\u201d the website said. \u201cUntil a software update is available, ensure you are following the instructions below to prevent the issue from occurring,\u201d it advised doctors.<\/p>\n
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company\u2019s primary concern, and certain issues \u201ccan be safely and effectively remedied with a correction on site.\u201d<\/p>\n
Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.<\/p>\n
\u201cBut, I mean, then you could ask, \u2018Well, why don\u2019t they just disable the view [of the brain] that\u2019s bugged?\u2019\u201d Everson said. \u201cWhy would they give you the option of looking at an inaccurate one?\u201d<\/p>\n
\u201cThat\u2019s kind of a strange solution,\u201d he said.<\/p>\n
The FDA lists the 2021 recall as still open<\/a>, explaining \u201cnot all products have been corrected or removed.\u201d<\/p>\n
That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.<\/p>\n
In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they \u201c had almost no speech for two days<\/a>,\u201d according to a Medtronic report. In the report, Medtronic said there was \u201cinsufficient information to determine the relationship of the software to the reported issue.\u201d<\/p>\n
In a February 2024 case, after brain surgery, an MRI found that the operation \u201c missed the tumor<\/a>\u201d and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.<\/p>\n
In March 2024, Medtronic recalled versions of StealthStation S8<\/a> without removing them from hospitals. The company said at the time that it would provide a software update<\/a>.<\/p>\n
\u201cSoftware updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,\u201d Medtronic\u2019s Winkels told KFF Health News in a July email. \u201cWhile the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.\u201d<\/p>\n
In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of \u201cdestruction of the impeller blades,\u201d which could cause \u201clow flow\u201d and \u201cembolization of the fractured impeller material,\u201d an entry on the FDA website<\/a> said.<\/p>\n
\u201cClinicians are cautioned to position the Impella system carefully in patients,\u201d the FDA website said, among other instructions.<\/p>\n
The updated instructions \u201cprovide technical guidance to mitigate the risk of rare complications,\u201d Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events \u201crelated to product design or manufacturing,\u201d Carbain said.<\/p>\n
Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.<\/p>\n
The devices \u2014 which are placed in the aorta, a major artery, to assist the heart \u2014 were the subject of eight Class I recalls<\/a> from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.<\/p>\n
In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports<\/a> related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.<\/p>\n
During the summer of 2023, the FDA noted that \u201calternative treatments are limited\u201d and said the devices could continue to be used<\/a>.<\/p>\n
But, in May, the FDA changed its stance. The agency advised health care facilities to \u201ctransition away from these devices and seek alternatives, if possible.\u201d<\/p>\n
\u201cThese recommendations are based on our continued concerns\u201d that the manufacturer \u201chas not sufficiently addressed the problems and risks with these recalled devices.\u201d<\/p>\n
Getinge sent KFF Health News written answers from Elin Frostehav, the company\u2019s president of Acute Care Therapies.<\/p>\n
\u201cThere is no question that we would have liked to have solved these issues in full much earlier,\u201d she said.<\/p>\n
As a result of the FDA\u2019s May action, the company \u201cimmediately paused proactive marketing\u201d of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.<\/p>\n
\u201cWe are working with the agency to finalize remediation and product update solutions,\u201d Frostehav said.<\/p>\n
\u2018Known Possible Complications\u2019<\/strong><\/p>\n
Abbott\u2019s MitraClip system includes tiny clips implanted in the heart\u2019s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.<\/p>\n
An image from the 2019 FDA document<\/a> showing a clip implanted to hold flaps of the heart\u2019s mitral valve together. MitraClip is deployed via a catheter threaded through a major blood vessel.(Photo illustration of 2019 FDA document)<\/span><\/figcaption><\/figure>\n
Worldwide, more than 200,000 people<\/a> have been treated with MitraClip, according to an Abbott website.<\/p>\n
The 2016 MitraClip recall described cases in which \u201cthe user was unable to separate<\/a> the implantable Clip from the delivery system.\u201d<\/p>\n
In a news release<\/a> at the time, Abbott said it had \u201creceived a small number of reports\u201d in which that happened.<\/p>\n
Those cases \u201cresulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,\u201d the FDA said in a 2016 notice<\/a>. \u201cThere was one patient death in these cases as a result of severe comorbidities following surgery.\u201d<\/p>\n
Years later, something similar happened.<\/p>\n
In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn\u2019t separate the clip from the delivery system<\/a>, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system \u201chad to be cut down in order to detach the clip.\u201d<\/p>\n
The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.<\/p>\n
The patient \u201ccoded\u201d the next day and died from an aortic bleed, the report said.<\/p>\n
In the report to the FDA, the manufacturer blamed \u201ccase-specific circumstances.\u201d<\/p>\n
\u201cCardiac arrest, hemorrhage and death are listed\u201d in the device instructions \u201cas known possible complications associated with mitraclip procedures,\u201d the company said. \u201cThere is no indication of a product issue with respect to manufacture, design or labeling.\u201d<\/p>\n
The third MitraClip recall<\/a>, initiated in September 2022, cited an \u201cincrease in clip locking malfunctions.\u201d<\/p>\n
Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then<\/a>. Treatment with MitraClip \u201cremains within the anticipated risk levels,\u201d the company told customers.<\/p>\n
As with the two earlier recalls, the third advised doctors to follow the device\u2019s instructions. But the 2022 recall identified a contributing factor: the way the device was made.<\/p>\n
\u201cAbbott has identified a contributing cause \u2026 as a change in the material properties of one of the Clip locking components,\u201d the company said in a 2022 letter to customers<\/a>.<\/p>\n
\u201cAbbott is working on producing new lots with updated manufacturing processing and raw material,\u201d the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.<\/p>\n
Six days later, a clip opened while locked<\/a> and a patient died, according to a report the manufacturer submitted to the FDA.<\/p>\n
\u201cThere is no evidence that death was related to the device but it was likely related to the procedure,\u201d Abbott wrote.<\/p>\n
Now, almost two years later, the 2022 recall remains open, according to the FDA website, and \u201cnot all products have been corrected or removed.\u201d<\/p>\n
KFF Health News data editor Holly K. Hacker contributed to this report.<\/em><\/p>\n
*If you\u2019ve had an experience with a medical device and would like to tell KFF Health News about it, <\/em>click here<\/em><\/a> to contact our reporting team.<\/em>**<\/p>\n*
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