- FDA has labeled Medtronic's recall of the HawkOne Directional Atherectomy System a Class I event, adding to the medtech's already long list of recent product safety problems.
- Medtronic initiated the recall on Dec. 6 due to the risk that guidewires in the catheters can alter their positions when force is applied during use. The malfunction can result in the catheter tip breaking off or separating, which could then cause a tearing of the inside wall of an artery, a rupture or break of an artery, decreased blood flow to parts of the body due to a blocked artery, and/or blood vessel complications that may require surgical repair, according to FDA's Friday notice. Product malfunctions can also require additional procedures to capture and remove the detached and/or migrated tips.
- There have been 163 complaints about the device issue, and there have been 55 injuries and no deaths reported, FDA said. The recall affects 95,110 devices in the U.S.
Medtronic faces a growing list of product safety problems. FDA posted 10 Class I recall notices for the company in 2021, including an expanded recall of certain MiniMed insulin pumps and several recalls for the HeartWare ventricular assist device, which was eventually pulled from the market in June.
In 2022, FDA has posted three Class I recall notices for the medtech giant, including a recall for Medtronic's Covidien unit.
Medtronic's diabetes group also received a warning letter from the FDA in December that outlined multiple product safety problems for several MiniMed insulin pump series, including not properly classifying the risk to patients and not initiating a recall despite over 57,000 medical device reports made to the agency over three years.
CEO Geoff Martha addressed the mounting recalls and product safety issues during last week's J.P. Morgan Healthcare Conference, claiming that more accountability will take place in the company.
"Medtronic has had a number of recalls in the past year relating to issues that originated over the past decade. We take responsibility for this, and we're focused on getting this right," Martha said. "At the enterprise level, we're increasing accountability and aggressively accelerating plans to enhance patient safety and improve our quality performance. This is my top priority and the top priority of the leadership team."
The recent problems may have financial or market consequences for the company going forward. For example, Martha said the FDA warning letter creates uncertainty around the approval timeline for its MiniMed 780G pump, a crucial product for the medtech as it is facing strong competition from insulin pump companies like Tandem Diabetes Care and Insulet.
In its recall letter, Medtronic reiterated the "existing warnings and precautions" in the HawkOne system's instructions for use regarding risk with catheter tip damage caused by guidewires moving, according to FDA.
"The consignees are informed that no updates will be applied to the current HawkOne [instructions for use] at this time and patients should continue to be monitored per the practice's normal follow-up procedures," according to the agency's recall database. "There are no actions required for patients where HawkOne was previously used during a procedure and there are no product retrievals or disposals requested by Medtronic."
FDA stated in its Friday notice that Medtronic told customers to share the recall information with people in the organization and any organization where products were transferred, to check the system before use and complete a "customer confirmation form" that was enclosed in the recall letter.