Medtronic’s 6-F TurboHawk Plus Recalled for Risk of Tip Damage

February 7, 2022—Medtronic advised that the company recently initiated a voluntary recall related to the risk associated with tip damage caused by guidewire prolapse in its 6-F TurboHawk Plus directional atherectomy system.

Medtronic stated that this latest communication was issued to reiterate the existing warnings and precautions in the TurboHawk Plus instructions for use (IFU) related to the risk associated with tip damage caused by guidewire prolapse. There is no product retrieval or disposal requested at this time.

Additionally, there are no actions required for patients treated with the TurboHawk Plus 6-F or any Medtronic directional atherectomy devices. Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols, stated the company.

The recall applies to approximately 800 TurboHawk Plus devices. There have been no reports of tip damage and no reports of injury or death on the TurboHawk Plus device, stated the company.

As noted by Medtronic, the company recently issued a recall with warnings and precautions on the IFU related to instances of guidewire prolapse causing tip damage for the HawkOne directional atherectomy system. Based on design similarities to HawkOne, the same warnings and precautions apply to TurboHawk Plus device. The company noted that this is not a new issue.