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.
- HawkOne Directional Atherectomy System
- Product Codes and Lot Numbers: See Recall Database Entry
- Devices Recalled in the United States: 95,110
- Distribution Date: January 22, 2018 to October 4, 2021
- Date Initiated by Firm: December 6, 2021
The HawkOne 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.
Reason for Recall
Figure 1: Prolapsed Guidewire
Medtronic Inc. is recalling this product due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use (see Figure 1). 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.
There have been 163 complaints about this device issue. There have been 55 injuries and no deaths reported about this device issue.
Who May Be Affected
- Health care providers using the affected HawkOne Directional Atherectomy System
- Patients receiving treatment with the affected HawkOne Directional Atherectomy System
What to Do
On December 6, 2021, Medtronic Inc. sent an “Urgent Medical Device Notice" letter to customers requesting they:
- Share with all those who need to be aware within the organization or to any organization where the products have been transferred.
- Before using the HawkOne Directional Atherectomy System, review the “Instructions For Use” included with the product, noting the warnings and precautions listed in the “Urgent Medical Device Notice” letter.
- Complete the Customer Confirmation Form enclosed in the “Urgent Medical Device Notice" letter and email to [email protected].
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.