Medtronic Inc (NYSE: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.
- Price Action: MDT shares are down 0.41% at $105.67 during the market session on the last check Friday.
