Medtronic Recalls TurboHawk Directional Atherectomy System

Medtronic Recollects TurboHawk Directional Atherectomy System

Medtronic has recalled 686 TurboHawk Plus Directional Atherectomy Methods as a result of there’s a danger that the guidewire inside the catheter could transfer downward or prolapse throughout use, which can harm the tip of the catheter.

If the guidewire strikes down or prolapses throughout use, the catheter tip could break off or separate, resulting in critical antagonistic occasions together with arterial dissection or rupture, ischemia, and/or blood vessel issues that would require surgical restore and extra procedures to seize and take away the indifferent and/or migrated (embolized) tip.

It is the identical situation that led Medtronic to recall 95,110 HawkOne Directional Atherectomy Methods in January, as beforehand reported by theheart.org | Medscape Cardiology.  

The US Meals and Drug Administration (FDA) has recognized each remembers as a category I remembers, probably the most critical kind, due to the potential for critical harm or dying.

Each the HawkOne and the TurboHawk Directional Atherectomy programs are used throughout procedures meant to take away blockage from peripheral arteries and enhance blood movement.

As of February 7, there have been no reported accidents or deaths related to the TurboHawk programs.

As of January 21, 55 accidents, no deaths, and 163 complaints have been reported for the recalled HawkOne programs.

The recalled TurboHawk units have been distributed in the US between September 27, 2021, and January 25, 2022.

Product codes and lot numbers pertaining to the small vessel and huge vessel units are listed on the FDA web site.

Medtronic despatched an pressing subject security discover to prospects on February 4, requesting that they alert events of the defect, assessment the directions to be used earlier than utilizing the gadget, and word the warnings and precautions listed within the letter.

Prospects have been additionally requested to finish the enclosed affirmation kind and e-mail it to [email protected] Questions on this recall might be directed to the native subject consultant or Medtronic customer support at 800-854-3570.

Healthcare suppliers can report antagonistic reactions or high quality issues they expertise utilizing these units to the FDA’s MedWatch program.

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