Medtronic has seen 23 serious medical device recalls in two years

Medtronic, hit by a large number of serious medical device recalls in recent years, says it is tightening its internal reviews for acquiring new products.

The Fridley-based company faces 11 Class I recalls in 2022 and 12 in 2021 – far more than usual. The US Food and Drug Administration reserves its Class I status for the most serious, life-threatening medical device problems.

For comparison, between 2017 and 2020, Medtronic averaged five Class I recalls a year.

Seven of the company’s 23 recalls over the past two years have been related to the Heartware Ventricular Assist Device (HVAD), which Medtronic acquired in 2016. Four of those recalls were in 2021. There were three this year.

“Acquired products (such as the HVAD) are the largest contributors to Class I … growth,” Medtronic spokeswoman Erica Winkles said. “Our processes for assessing and integrating received products have been improved to minimize the contribution of received products to product quality issues going forward.”

As of June 2021, when Medtronic stopped selling the affected products, the company said 14 deaths were linked to HVAD device defects. So far, Medtronic’s 2022 recalls have been linked to fewer deaths.

The rise in returns for the world’s largest medical device maker is troubling to many.

“There’s clearly a problem when a company has so many recalls — Class I recalls on critical, potentially life-saving devices,” said Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research. does,” said Diana Zuckerman, president of a nonprofit think tank that works to improve. Safety and effectiveness of medical products.

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Medtronic made a big bet on HVAD technology when it acquired Massachusetts-based HeartWare International Inc. in 2016. acquired for $1.1 billion. But it has cost Medtronic just as much to overcome a series of legal and regulatory problems with the product. Medtronic has taken $1.1 billion in charges associated with exiting the HVAD business, according to details in a financial filing earlier this year.

Acquiring technology from other companies, Zuckerman said, does not relieve Medtronic of its responsibilities for device safety. One problem, he said, stems from the way the FDA regulates medical devices, many of which — unlike pharmaceuticals — don’t require clinical trial data to be collected before approval.

“This is a well-known weakness of the FDA, but it puts the onus on the company,” he said. “Regardless of what the FDA requires them to do, companies have to be really careful that their product is safe.”

When the pandemic hit, the FDA halted most foreign and domestic inspections except for those deemed mission critical.

Class I medical device recalls are increasing across the industry, said Rachna Shah of the University of Minnesota’s Carlson School of Management, who studies medical device and pharmaceutical recalls.

“In general, there are more recalls,” Shah said. One possible explanation for the more serious recalls is that device companies may be less rigorous in their product safety reviews because the FDA was doing less oversight, he said.

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She expects marginally higher returns to continue through the end of next year.

But Medtronic’s return rate significantly outpaces its competitors. Abbott, based in Illinois, has only missed one this year. Massachusetts-based Boston Scientific Corp. has no recall in 2022. Illinois-based Baxter International has five returns. All three companies have operations in Minnesota.

Medtronic, with fiscal 2022 sales of $31.7 billion, is the largest medical device maker in the industry, which puts it at greater risk of recalls because it makes more products than anyone else.

Abbott has different business lines. Its medical device sales in 2021 were $14.4 billion. Boston Scientific posted revenue of $11.9 billion. Not counting its pharmaceutical division, Baxter had $10.5 billion in medical device sales last year. Medtronic’s revenue is equal to 86% of the combined sales of these three companies.

“The number of Class 1 relapses in recent years is unusual for us,” said Medtronic’s Winkels.

Medtronic has established a centralized clinical safety organization and added a Patient Safety and Risk Board. The board includes senior leaders from several departments – clinical safety, quality, regulatory and legal – and provides oversight of patient safety decisions. Both were implemented in 2022.

“We have reviewed our end-to-end quality performance, and we are focused on making sustainable improvements,” said Noel Colon, Medtronic’s chief quality officer. He said the company has increased oversight in areas such as risk assessment, product design and integration of acquired treatments and solutions.

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Medical device recalls are often initiated by the company, which sends alerts to doctors and patients when a problem is detected. The FDA typically doesn’t classify the severity of a recall — Class I, II or III — until months later, meaning a recall listed in the FDA’s 2022 index would be the first time a company launched in 2021. Will be.

Unlike food and consumer product recalls, medical device recalls do not necessarily mean that the product is removed from the patient and returned to the company. Recalls often involve adjustments to device settings, software updates or relabeling of a product.

In the event of any recall, Medtronic conducts a thorough investigation to resolve the issue and prevent recurrence, Winkles said.

This year’s high number of recalls prompted Medtronic to implement new plans and programs that include more rigorous review of device risk assessments.

Winkles said the company has “leveraged external experts to complement independent perspectives, subject matter expertise and internal Medtronic resources.”

In September, the FDA identified the company’s recall of NIM endotracheal tubes as a Class I case. Medtronic reported 15 complaints, two deaths and three injuries related to the device between March 31, 2020 and March 31, 2022.

The FDA issued a Class I recall of Cobalt, Cobalt XT and Crome defibrillators in August because of their ability to deliver fewer shocks to the patient. This issue was resolved with a software update. Medtronic reported 27 complaints and zero deaths or injuries.

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