The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.
So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.
The latest recall covers 95,110 HawkOne directional atherectomy systems in the U.S. that were distributed between Jan. 22, 2018, and Oct. 4, 2021. Medtronic initiated the recall on Dec. 6, 2021, having received 163 complaints and 55 reports of injuries related to the issue. No related deaths have been reported.
Fridley, Minnesota-based Medtronic designed HawkOne with a catheter and a cutter driver for use during procedures to remove blockages from peripheral arteries and improve blood flow. The recall is due to the risk of the guidewire within the catheter moving down or prolapsing when force is applied.
Should this happen, the catheter tip may break off or separate, which could lead to serious adverse events such as a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia) and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip, according to the FDA notice.
According to the FDA’s database, the company had 10 recalls categorized as Class I in 2021, including devices such as its MiniMed insulin pumps, its Pipeline Flex embolization device and its HeartWare ventricular assist device (HVAD).
Medtronic issued the following statement in response to the latest recall:
“In our letter to customers, Medtronic noted that a small number of customer reports of tip damage (at a rate of 0.168% when compared to quantity of devices distributed) during the use of the 6 Fr HawkOne devices. While most of these instances were resolved without patient issue, a small number required endovascular retrieval (0.033%) or open surgical retrieval (0.028%). No patient deaths have been reported related to this issue.
“There are no product retrievals or disposals requested associated with this recall. The purpose of this recall is to reiterate existing warnings and precautions in the HawkOne Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire prolapse. Additionally, there are no actions required for patients treated with the HawkOne 6 Fr or any Medtronic directional atherectomy devices. Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols.”