Medtronic and the FDA are expanding the reach of a Class I recall handed down in January for the medtech giant’s catheter designed to clear out clogged arteries.
The previous recall covered more than 95,000 devices distributed in the U.S. for Medtronic’s HawkOne system after it was discovered that the catheter’s guidewire could become bent and stick outwards during use within a blood vessel.
The company extended its recall in early February, notifying healthcare providers to include its TurboHawk Plus system, which shares the same risks due to design similarities between the two devices. Though there had been no reported injuries or deaths at the time of the recall, the FDA this week gave the action a Class I designation, the agency’s most serious.
The latest recall includes 686 devices distributed in the U.S. between September 2021 and January 2022 after the TurboHawk Plus received an FDA 510(k) clearance in August 2021.
Designed to improve circulation in the legs, the TurboHawk Plus directional atherectomy system includes a catheter and a spinning cutter to grind up and remove hardened, calcified plaques from the inside of arteries, like the HawkOne before it.
In both devices, a prolapsed guidewire could cause the tip of the catheter to break off and become lodged within the blood vessel or even cause tears in the artery wall, with either event requiring additional surgery.
In a statement, Medtronic said the recall is not due to a newly reported issue, and the company has not requested any product retrievals or disposals by providers. In addition, there are no actions required for patients who have been treated with the TurboHawk Plus, the HawkOne or any Medtronic directional atherectomy device.
Medtronic has seen a string of recent recalls after problems last year with its HVAD implant kits and its HeartWare blood pump, which has since been discontinued. In addition, tens of thousands of angiography guidewires were called back after not being properly sterilized before shipping.
The company also expanded recalls of its MiniMed insulin pumps, which affected a handful of models in its 600 series and more than 463,000 devices distributed between 2015 and 2020.