Dive Brief:
- Medtronic is recalling certain IN.PACT Admiral and IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty balloon catheters after devices were damaged due to manufacturing problems.
- Pouches on the catheters were found to be damaged, causing the loss of sterility in the devices, according to a March 31 press release from Medtronic. The recall affects 6,000 IN.PACT Admiral catheters and three IN.PACT AV catheters, and the company is telling customers to "immediately quarantine and return the product to Medtronic, as well as send back a signed confirmation form."
- Medtronic has received no complaints due to the issue and there have been zero reports of patient injuries or deaths, according to the statement. The company said that no action is needed from patients "where the affected IN.PACT Admiral and IN.PACT AV catheters were used during a procedure."
Dive Insight:
This latest recall adds to Medtronic’s ongoing product safety issues. The medtech giant has had four Class I recalls posted by the FDA already this year and 10 in 2021, including multiple Class I recalls for a problematic HeartWare pump that was ultimately pulled off the market.
Medtronic also announced in December that its diabetes group received an FDA warning letter for numerous product safety issues found during a facility inspection. The warning letter not only highlighted current problems with the diabetes group but is likely holding up the review and eventual launch of two key products.
In January, CEO Geoff Martha addressed the consistent recalls and safety issues with the company. The CEO said during the J.P. Morgan Healthcare conference that recalls will be a "top priority."
"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 most recent catheter recall was due to damaged pouches, and the damage was found during a routine inspection. According to the company, a change implemented to one manufacturing line was found to be the cause, and all batches manufactured on the line are being retrieved.
Medtronic said in the statement that the problem was fixed and production on all lines was paused until a follow-up packaging inspection was completed.
