FDA designates recall of two sheaths as class 1

The FDA has designated Terumo Medical’s product recall of a balloon-expandable transfemoral system and a re-collapsible balloon access system as a class 1 recall, the most serious kind. The recall affects 3,474 systems manufactured and distributed between June 22, 2016, and March 13, 2019.

Potential tip dislodgement from the outer rim of the sheath led to the recall of all lots of the balloon-expandable transfemoral system (SoloPath balloon-expandable transfemoral introducer system) and the re-collapsible balloon access system (SoloPath re-collapsible access system), according to a MedWatch report from the FDA. This may lead to vessel dissection, pseudoaneurysm, false lumen, vessel perforation, hemorrhage, vessel disruption and the inability to transition from the skin to the iliac artery.

These systems are typically used for the insertion of catheters or other devices in a patient’s femoral or iliac arteries to reduce friction and minimize trauma during procedures such as transcatheter aortic valve replacements and peripheral procedures

Although no deaths have been reported, there have been 14 reports of related device malfunctions with two injuries, according to the report.

Terumo Medical distributed a product discontinuation notice and a voluntary recall notice to customers on April 30 alerting them of the issue, to review all related products and to complete a medical device recall response form even if no products need to be returned, according to the report. The company also urged health care providers to consider other supplies for these systems.