Medtronic, battered by a high number of serious medical device recalls in recent years, says it is toughening its internal assessments for acquiring new products.
The company, operationally based in Fridley, has been hit with 11 Class I recalls in 2022 and 12 in 2021 — far more than usual. The U.S. 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 about five Class I recalls a year.
Seven of the company's 23 recalls in the last 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 biggest contributor to Class I … growth," said Erika Winkels, a spokeswoman for Medtronic. "Improvements have been made to our process for assessing 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 beleaguered product, the company said 14 deaths had been linked to defects with the HVAD device. So far, Medtronic's 2022 recalls are linked to a small number of deaths.
The uptick in recalls at the world's largest medical device maker is troubling to many.
"Clearly there's a problem when a company has this many recalls — Class I recalls on important, potentially life-saving devices," said Diana Zuckerman, president of Washington D.C.-based National Center for Health Research, a nonprofit think tank that works to improve the safety and effectiveness of medical products.
Medtronic bet big on HVAD technology when it acquired Massachusetts-based HeartWare International Inc. for $1.1 billion in 2016. But it has cost Medtronic just as much to unspool the product's string of legal and regulatory problems. According to details in a financial filing earlier this year, Medtronic has taken $1.1 billion in charges connected to exiting the HVAD business.
Acquiring technology from other companies, Zuckerman said, does not absolve Medtronic of its device safety responsibilities. She said one issue stems from the way the FDA regulates medical devices, many of which — unlike pharmaceuticals — are not required to submit any clinical trial data prior to approval.
"That is a known weakness of the FDA, but it does put the onus on the company," she said. "Regardless of what FDA requires them to do, companies should be really careful making sure their product is safe."
When the pandemic hit, the FDA stopped most foreign and domestic inspections except for cases considered mission critical.
Class I medical device recalls are increasing across the industry, said Rachna Shah of the Carlson School of Management at the University of Minnesota, who studies medical device and pharmaceutical recalls.
"In general, recalls are higher," Shah said. She said one possible explanation for more serious recalls is that device companies may have become less rigorous in safety reviews for their products as the FDA was doing less monitoring.
She expects marginally higher recalls to continue through the end of next year.
But Medtronic's rate of recalls has significantly outpaced its competitors. Illinois-based Abbott has seen only 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 of those companies have operations in Minnesota.
Medtronic, with fiscal 2022 sales of $31.7 billion, is the largest medical device manufacturer in the industry, which puts it at higher recall risk because it simply makes more products than anyone else.
Abbott has diverse business lines; 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 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 established 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 provides oversight for patient safety decisions. Both were implemented in 2022.
"We have examined 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 such areas as risk assessment, product design and integration of acquired therapies and solutions.
Medical device recalls often begin with the company, which sends out alerts to doctors and patients when a problem is discovered. The FDA doesn't typically classify the severity of the recall — Class I, II or III — until a few months later, meaning that a recall listed on the FDA's index for 2022 may have first been launched by the company in 2021.
Unlike food and consumer product recalls, a medical device recall does not necessarily mean that the product is removed from a patient and returned to the company. Recalls can often involve adjustments to device settings, software updates or re-labeling a product.
In the case of any recall, Medtronic undertakes a detailed investigation to resolve the issue and prevent its recurrence, Winkels said.
This year's high number of recalls 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 external experts for independent perspective, subject matter expertise and to supplement 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 due to the potential for delivering lower-than-necessary shocks to the patient. That issue was addressed with a software update. Medtronic reported 27 complaints and zero deaths or injuries.
