Medtronic’s TurboHawk Plus Recall Deemed Class I

The U.S. Food and Drug Administration (FDA) has deemed Medtronic’s Feb 4 recall of its TurboHawk Plus directional atherectomy system as Class I.
 
TurboHawk Plus consists of a catheter and cutter driver, which are used to remove bloackage from peripheral arteries and improve blood flow. The product was recalled over design similarities with its HawkOne directional atherectomy system recently recalled for correction.
 
The catheter’s guidewire risks moving downward or prolapsing when force is applied during use. This can cause the catheter tip to break off or separate, potentially bringing about arterial dissection or rupture, ischemia, or blood vessel complications requiring followup oricedures to capture and remove the detached and/or embolized tip.
 
686 devices have been recalled in the U.S. As of Feb. 7, there had been no reported injuries or deaths.
 
Medtronic did not request TurboHawk Plus retrievals or disposals.