Medtronic Inc. is recalling this product due to the risk of the tip of the catheter becoming damaged during use, which may include the catheter tip breaking off or separating. If this occurs, this could lead to serious adverse events such as a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
UPDATE
Medtronic has released the following statement:
In accordance with our commitment to patient safety, Medtronic recently initiated a voluntary recall to customers related to the risk associated with tip damage caused by guidewire prolapse in its 6 French (6Fr) TurboHawk™ Plus directional atherectomy system. This recall has been classified by the FDA as a Class I recall. This communication is meant 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.
Medtronic recently issued IFU warnings and precautions related to instances of guidewire prolapse causing tip damage for the HawkOne™ Directional Atherectomy System. Based on design similarities, the same warnings and precautions apply to TurboHawk Plus. This is not a new issue.
There have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device. There are no product retrievals or disposals requested.
There are no actions required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices. Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols.
