Medtronic, hurt by a string of major medical device recalls in recent years, says it is tightening its internal evaluations to acquire new products.
The company, which has operations based in Fridley, was hit with 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 medical devices with the most serious life-threatening problems.
By comparison, Medtronic is averaging about five class recalls per year between 2017 and 2020.
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; three were this year.
“Acquired products (such as HVAD) were the largest contributors to Class I … growth,” said Erika Winkels, a spokeswoman for Medtronic. “Enhancements have been made to our process for evaluating and integrating acquired products to reduce the contribution of acquired products to product quality issues moving forward.”
As of June 2021, when Medtronic stopped selling the blocked product, the company said 14 deaths were linked to defects in the HVAD device. So far, Medtronic’s 2022 recalls have involved a small number of deaths.
The growing number of recalls at the world’s largest medical device maker has many worried.
“Obviously, there is a problem when a company has so many recalls. Class I recalls are important, potentially life-saving devices,” said Diana Zuckerman, president of the Washington-based National Center for Health Research, a nonprofit think tank that works to improve. safety and efficacy of medical products;
Medtronic made a big bet on HVAD technology when it acquired Massachusetts-based HeartWare International Inc. for $1.1 billion in 2016. Medtronic took a $1.1 billion charge to exit the HVAD business, according to details in financial filings earlier this year.
Acquiring technology from other companies, Zuckerman noted, does not absolve Medtronic of its responsibilities for device safety. He said one problem stems from the way the FDA regulates medical devices, most of which, unlike pharmaceuticals, are not required to submit any clinical trial data before approval.
“It’s a known weakness of the FDA, but it puts the responsibility on the company,” he said. “Regardless of what the FDA requires of them, companies have to be really careful to make sure their products are safe.”
When the pandemic hit, the FDA suspended most foreign and domestic 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, who studies medical device and pharmaceutical recalls.
“In general, there are more recalls,” said Shah. He said one possible explanation for the more serious recalls is that device companies may have been less rigorous in their product safety reviews because the FDA was doing less monitoring.
He expects marginally higher withdrawals to continue into late next year.
But Medtronic’s recall rate far outpaced its competitors. Abbott, Illinois, has seen just one recall this year. Boston Scientific Corp. of Massachusetts had no recall in 2022. Baxter International of Illinois had five recalls. All three of those companies operate in Minnesota.
Medtronic, with fiscal 2022 sales of $31.7 billion, is the largest medical device maker in the industry, putting it at greater risk of recalls because it simply makes more products than anyone else.
Abbott has different business lines. its medical device sales in 2021 were $14.4 billion. Boston Scientific’s revenue was $11.9 billion. Excluding its pharmaceuticals division, Baxter had medical device sales of $10.5 billion last year. Medtronic’s revenue is equivalent to 86% of the combined sales of those three companies.
“The number of Class 1 recalls in recent years is atypical for us,” Medtronic’s Winkels said.
Medtronic has created a central medical safety organization and added a patient safety and risk board. The board includes senior leaders from several departments—medical safety, quality, regulatory, and legal—and oversees patient safety decisions. Both were implemented in 2022.
“We’ve looked at our end-to-end quality performance and are focused on 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 out alerts to doctors and patients when a problem is detected. The FDA typically doesn’t classify the severity of a recall as Class I, II or III until several months later, meaning a recall listed on the FDA’s 2022 index could be the first to be initiated by a company in 2021.
Unlike food and consumer product recalls, a medical device recall does not necessarily mean that the product is removed from the patient and returned to the company. Recalls can often include adjustments to device settings, software updates, or product relabeling.
With any recall, Medtronic conducts a thorough investigation to resolve the issue and prevent it from happening again, Winkels said.
This year’s high number of recalls prompted Medtronic to implement new plans and programs that include a more rigorous review of the device’s risk assessment.
Winkels said the company “leveraged the independent perspective of outside experts, subject matter expertise and leveraged Medtronic’s internal resources.”
In September, the FDA recognized 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 recalled the Cobalt, Cobalt XT and Crome Class I defibrillators in August due to the possibility of delivering less than necessary shocks to the patient. That issue has been resolved with a software update. Medtronic reported 27 complaints and zero deaths or injuries.