Medtronic has recalled 686 TurboHawk Plus Directional Atherectomy Systems because there is a risk that the guidewire within the catheter may move downward or prolapse during use, which may damage the tip of the catheter.
If the guidewire moves down or prolapses during use, the catheter tip may break off or separate, leading to serious adverse events including arterial dissection or rupture, ischemia, and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip.
It’s the same issue that led Medtronic to recall 95,110 HawkOne Directional Atherectomy Systems in January, as previously reported by theheart.org | Medscape Cardiology.
The US Food and Drug Administration (FDA) has identified both recalls as a class I recalls, the most serious type, because of the potential for serious injury or death.
Both the HawkOne and the TurboHawk Directional Atherectomy systems are used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
As of February 7, there have been no reported injuries or deaths associated with the TurboHawk systems.
As of January 21, 55 injuries, no deaths, and 163 complaints were reported for the recalled HawkOne systems.
The recalled TurboHawk devices were distributed in the United States between September 27, 2021, and January 25, 2022.
Medtronic sent an urgent field safety notice to customers on February 4, requesting that they alert parties of the defect, review the instructions for use before using the device, and note the warnings and precautions listed in the letter.
Customers were also asked to complete the enclosed confirmation form and email it to email@example.com. Questions about this recall can be directed to the local field representative or Medtronic customer service at 800-854-3570.
Healthcare providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.