Medtronic Inc MDT is recalling HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use.
- FDA has identified this as a Class I recall, the most serious type of recall.
- The system consists of a catheter & cutter driver to be used during procedures intended to remove a blockage from peripheral arteries and improve blood flow.
- Related: Medtronic Shares Fall After FDA Warning Letter To Its Diabetes Business.
- In the case of a prolapsed guidewire, the catheter tip may break off or separate, resulting in serious adverse events.
- Adverse events include a tear along the inside wall of an artery, a rupture or breakage of an artery, a decrease in blood flow to a part of the body, and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the broken tip.
- There have been 163 complaints, with 55 injuries. But no deaths have been reported.
- Roughly 95,000 devices will be recalled distributed between January 22, 2018, to October 4, 2021.
- In a letter to customers, Medtronic noted that few customers reported tip damage (0.168% compared to the number of devices distributed) while using the 6FR HawkOne devices.
- While most of these instances were resolved without patient issues, a small number required endovascular retrieval (0.033%) or open-surgical retrieval (0.028%).
- There are no product retrievals, or disposals requested associated with this recall. The purpose of this recall is to reiterate existing warnings and precautions related to the risk associated with tip damage.
- Price Action: MDT shares are down 0.97% at $105.08 during the market session on the last check Friday.
Editor's note: The post has been updated to add additional context that Medtronic is not retrieving the product.
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