Medtronic has logged yet another Class I medical device recall, the FDA’s most serious type, after reports of injuries with its HawkOne system for clearing out clogged arteries.
The recall, launched by the medtech giant in early December 2021, covers more than 95,000 devices distributed in the U.S. since 2018.
It marks the latest to receive the FDA’s Class I label, following recent recalls for the company’s StealthStation neurosurgery software and its Puritan Bennett ventilators.
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The HawkOne system includes a catheter and a powered cutter that is designed to strip away plaque build-up inside peripheral arteries by spinning at up to 12,000 RPM. The problem is linked to the device’s guidewire, which can become bent and stick outwards during use.
This can lead to the catheter tip separating or breaking off, potentially leading to serious complications, including a ruptured or blocked blood vessel, which would require surgery to repair the artery and retrieve the device.
According to the FDA’s recall notice, the agency has received 163 complaints about the device, linked to 55 injuries and zero deaths.
In Medtronic’s December letter to healthcare providers, referenced in the FDA recall notice, the company did not request that the device be shipped back to the manufacturer. The letter also reiterated the existing warnings and precautions in the HawkOne’s instructions regarding the risk of prolapsed guidewires.
No action is required for patients who underwent procedures without incident, and current patients should be monitored per the practice's normal follow-up procedures, the company said.
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Before its recent string of recalls, Medtronic saw problems early last year with HVAD implant kits and its HeartWare blood pump—which has since been discontinued—as well as tens of thousands of angiography guidewires that were not properly sterilized before shipping.
The company also expanded ongoing recalls of its MiniMed insulin pumps, affecting a handful of models in its 600 series, and more 463,000 devices distributed between 2015 and 2020.