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.
- Product Names: TurboHawk Plus Directional Atherectomy System
- Product Codes:
- Manufacturing Dates: July 21, 2021 to November 25, 2021
- Distribution Dates: September 27, 2021 to January 25, 2022
- Devices Recalled in the U.S.: 686
- Date Initiated by Firm: February 4, 2022
The TurboHawk Plus Directional Atherectomy System consists of a catheter and a cutter driver. This device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
Figure 1: Prolapsed guidewire illustrated example
Reason for Recall
Medtronic is recalling (correcting) this product due to design similarities shared with another device that was recently recalled for correction. There is a risk of the guidewire within the catheter moving downward or prolapsing (See Figure 1) when force is applied during use. If this happens, the catheter tip may break off or separate and this could lead to serious adverse events including 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.
As of February 7, 2022, there have been no reported injuries or deaths associated with this problem.
Who May be Affected
- Health care providers using the affected TurboHawk Plus Directional Atherectomy System
- Patients receiving treatment with the affected TurboHawk Plus Directional Atherectomy System
What to Do
On February 4, 2022, Medtronic sent all affected customers an Urgent Medical Device Notice requesting they take the following actions:
- Be aware, there are no product retrievals or disposals requested by Medtronic.
- Share Notice with all those who need to be aware within your organization or to any organization where the products have been transferred.
- Prior to use, review the Instructions For Use (IFU) included with your product, noting the warnings and precautions listed in this letter.
- Complete the enclosed Customer Confirmation Form included with the Urgent Medical Device Notice and email to firstname.lastname@example.org.
Customers who have questions about this recall should contact their Medtronic Field Representative or call Medtronic Customer Service at (800) 854-3570.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.