Dive Brief:

• Medtronic is recalling 54,997 guidewire components used during angiography to place catheters into the vascular system because the devices were not sterilized before being shipped to hospitals.
• Two complaints were received, but there is potential for underreporting because physicians may not have known of the issue, FDA said in announcing the Class I recall. No deaths or injuries related to the issue were reported.
• Medtronic has had seven recalls labeled as Class I events by the FDA in 2021 alone, including three recalls that eventually led to the company pulling its HeartWare Heart Ventricular Assist Device system from the market in June.

Dive Insight:

Device recalls have challenged the medtech giant throughout 2021.

The company in February said it advised physicians to immediately stop using its Valiant Navion thoracic stent graft system as part of a voluntary recall after stent fractures were observed, and one patient died during a clinical trial. Medtronic CEO Geoff Martha said during an earnings call in May that the recall resulted in a $35 million hit to revenues in the fiscal fourth quarter, as well as lost share in the thoracic stent graft market.

Class I recalls involving device malfunctions, including three in 2021, were a factor leading to the company's decision last month to discontinue its HeartWare HVAD system, after 91 reports of injuries and 15 deaths linked to issues with the system. FDA advised doctors to stop new implants of the heart pump, which Medtronic acquired in its $1.1 billion acquisition of HeartWare International in 2016. Martha said pulling the product from the market was "clearly the right decision for patients."

Other recalls include issues affecting several models of the Bio-Console 560 Extracorporeal Blood Pumping Console and a list of implantable cardioverter defibrillators and cardiac resynchronization therapy devices.

Medtronic's latest recall, initiated by the company on May 4, involves guidewires for vascular procedures that were supposed to be shipped to a third party for sterilization and then further processed into kits. Instead, the devices were shipped directly to hospitals unsterilized.

A Class I recall is FDA's most serious designation. The agency said in its notice that patient exposure to the non-sterile angiographic guidewire components could result in serious adverse events such as infection, sepsis and death.

Medtronic has advised customers to quarantine all unused affected Angiographic Guidewire components and return them to the company. Customers are also advised to report adverse reactions or quality problems experienced with the device to FDA and Medtronic.

The devices were distributed in California, Kentucky, Louisiana, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas, Washington and Wisconsin. Outside of the U.S., the devices were also distributed in Australia.

Almost two years ago, Medtronic recalled more than 100,000 catheters of a different model — the 6 French Sherpa NX Active Guide Catheter — due to a risk of device fracture. The catheter is used to deliver stents and balloons and aids in contrast agent injection. No patient deaths or serious injuries were reported in that Class I recall