Medtronic has seen 23 serious medical device recalls in two years

Medtronic, hit by a slew of serious medical device recalls in recent years, says it is tightening up its internal reviews to acquire new products.

The company, with operational headquarters in Fridley, has been hit by 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 and life-threatening medical device problems.

For comparison, between 2017 and 2020, Medtronic had an average of five Class I recalls per year.

Seven of the company’s 23 recalls in the past two years are related to the HeartWare ventricular assist device (HVAD) that Medtronic acquired in 2016. Four of those recalls were in 2021; three were this year.

“Acquired products (such as HVAD) have been the largest contributor to Class I growth…” said Erika Winkels, a spokeswoman for Medtronic. “Improvements have been made to our acquired product evaluation and integration process to reduce the contribution of acquired products to product quality issues in the future.”

As of June 2021, when Medtronic stopped selling the embattled product, the company said 14 deaths had been linked to defects in the HVAD device. So far, Medtronic’s 2022 recalls are tied to a small number of deaths.

The rise in recalls at the world’s largest medical device maker is concerning to many.

“Clearly there is a problem when a company has so many recalls — Class I recalls of important devices that can save lives,” said Diana Zuckerman, president of the Washington, DC-based National Center for Health Research, a think tank group. nonprofit experts who work to improve the safety and efficacy of medical products.

Medtronic bet big on HVAD technology when it acquired Massachusetts-based HeartWare International Inc. for $1.1 billion in 2016. But Medtronic has had such a hard time sorting out the product’s array of legal and regulatory issues. According to details in a financial filing earlier this year, Medtronic has collected $1.1 billion in fees related to exiting the HVAD business.

Purchasing technology from other companies, Zuckerman said, does not relieve Medtronic of its device security responsibilities. He said one problem stems from the way the FDA regulates medical devices, many of which, unlike pharmaceuticals, aren’t required to submit clinical trial data before approval.

“That’s a 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 must take great care to make sure their product is safe.”

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

Class I medical device recalls are on the rise across the industry, said Rachna Shah of the University of Minnesota’s Carlson School of Management, which studies recalls of medical devices and pharmaceuticals.

“In general, withdrawals are higher,” Shah said. She said a possible explanation for more serious recalls is that device companies may have become less rigorous in their product safety reviews, since the FDA was doing less monitoring.

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

But Medtronic’s recall rate has significantly outpaced its competitors. Illinois-based Abbott has seen just one recall this year. Massachusetts-based Boston Scientific Corp. has had no recalls in 2022. Illinois-based Baxter International has had five recalls. All three companies have operations in Minnesota.

Medtronic, with fiscal 2022 sales of $31.7 billion, is the industry’s largest maker of medical devices, putting it at greater risk of recall because it simply makes more products than anyone else.

Abbott has several lines of business; its medical device sales for 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 revenues are equivalent to 86% of the combined sales of those three companies.

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

Medtronic has established a central medical safety organization and added a patient safety and risk board. The board includes senior leaders from various departments (medical safety, quality, regulatory, and legal) and oversees patient safety decisions. Both were implemented in 2022.

“We have examined our end-to-end quality performance and 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 therapies and solutions.

Medical device recalls often start with the company sending alerts to doctors and patients when a problem is discovered. The FDA typically does not classify recall severity (Class I, II, or III) until a few months later, which means the company may have first launched a recall listed on the FDA’s index for 2022 in 2021.

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

In the event of any recall, Medtronic undertakes a detailed investigation to resolve the issue and prevent a recurrence, Winkels said.

The large number of recalls this year prompted Medtronic to implement new plans and programs that include a more rigorous review of a device’s risk assessment.

Winkels said the company has “leveraged outside experts to gain independent perspective, subject matter expertise, and to complement Medtronic’s internal 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 the Cobalt, Cobalt XT and Crome defibrillators in August due to the possibility of delivering less than necessary shocks to the patient. That issue was fixed with a software update. Medtronic reported 27 complaints and zero deaths or injuries.