Medtronic recalled the HawkOne Directional Atherectomy System because the catheter tip can break off during use. The FDA classified the action as a Class I recall, which is its most serious type.
Tip damage can lead to arterial dissection, arterial rupture or ischemia, and complications that may require surgical repair. The recall covers 6F catheters in four catalog numbers, sold in the United States and worldwide.
No lawsuit, class action or MDL has been filed over the HawkOne. The FDA terminated the recall on October 2, 2024.
- Case or litigation name: No filed case
- Defendants: None named
- Court and docket number, when available: No filed case
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No filing yet
- Main allegations: No allegations pleaded; the FDA recall cites a risk of catheter tip damage, detachment and embolization
- Products or people involved: HawkOne 6F catheters, catalog numbers H1-S, H1-S-INT, H1-M and H1-M-INT, distributed January 22, 2018 to October 4, 2021
Table Of Contents
Latest HawkOne Directional Atherectomy System Lawsuit Updates
October 2, 2024: FDA Lists the HawkOne Recall as Terminated
The FDA lists both HawkOne recalls as terminated, with a termination date of October 2, 2024. The first, Z-0450-2022, covers catalog numbers H1-M and H1-M-INT [1].
The second record covers catalog numbers H1-S and H1-S-INT. The recalling firm named in the FDA’s records is Medtronic, listed as ev3 Inc.
March 9, 2022: Medtronic Also Recalls TurboHawk Plus
MD+DI reported that Medtronic was also recalling, or correcting, its TurboHawk Plus Directional Atherectomy System because of design similarities with the HawkOne [2].
The notice covered 686 U.S. devices distributed between September 27, 2021 and January 25, 2022. The report appeared on March 9, 2022.
January 21, 2022: FDA Classifies the Recall as Class I
The FDA classified the HawkOne recall as Class I in a bulletin sent on January 21, 2022. The FDA bulletin reported 163 complaints about the device issue, 55 injuries and no deaths [3].
January 19, 2022: FDA Posts Two Recall Records
The FDA posted two recall records for the HawkOne event [4]. Z-0450-2022 lists 71,260 units, and the second record lists 28,094 units. Both records give the cause as labeling design. The unit counts are worldwide figures.
December 6, 2021: Medtronic Starts the Recall
Medtronic began the recall on December 6, 2021 by sending customers an Urgent Medical Device Notice letter. The FDA record lists the same start date.
Endovascular Today reported its own count of 95,110 devices distributed from January 22, 2018 to October 4, 2021 [5].
What Is a Directional Atherectomy System?
According to the FDA recall record, the HawkOne “is intended for use in atherectomy of the peripheral vasculature.” The record says it treats “severely calcified lesions” when used with the SpiderFX device [6].
The recall concerns the HawkOne 6F catheter made by Medtronic. The catheter tip is the part the recall says can be damaged during use.
Who May Be Affected?
You may be affected if you had a peripheral artery atherectomy with a HawkOne 6F catheter. The recall covers catalog numbers H1-S, H1-S-INT, H1-M and H1-M-INT, distributed before the recall began.
The FDA record says the device is not meant for coronary, carotid, iliac or renal vessels. Medtronic said no action is needed for patients treated with the HawkOne earlier.
Whether you have a claim depends on an individual legal review of your procedure, your medical records and when your complications began.
Reported Injuries or Damages
In its January 21, 2022 bulletin, the FDA named a tear in an artery wall, a ruptured artery and reduced blood flow. It also warned of blood vessel problems that could need surgical repair.
Medtronic told Endovascular Today that tip damage was reported at a rate of 0.168% of devices distributed. The company said most cases were resolved without patient issue and reported no patient deaths.
Recall and Regulatory Background
Medtronic recalled the HawkOne because the guidewire inside the catheter can move down or prolapse when force is applied. If that happens, the catheter tip may break off or separate.
Medtronic asked customers to share the notice and review the warnings in the Instructions for Use. Customers were to return the Confirmation Form. FDA explains recall classes in its medical device recall guide [7].
Evidence to Preserve
Keep these records. They may help show what happened during a HawkOne procedure and after it:
- The catalog number, lot number and bar code from the device packaging or procedure record
- Procedure and operative reports that name the device used
- Hospital records and device-use records from your stay
- Scans and images taken before and after the procedure
- Records of any later procedure to remove a broken tip
- Medical bills and messages with your doctor or Medtronic
- A daily journal of your symptoms and recovery
Filing Deadlines
State law sets the time limit for an injury claim. The limit depends on where you live, and on when your injury and its link to the HawkOne came to light.
A late filing can end a claim, even if the evidence is good. Talk to a lawyer promptly so a deadline does not pass while you collect records.
Frequently Asked Questions
Which FDA Recall Class Is the Most Serious?
The most serious FDA recall class is Class I. The FDA defines it as a situation where there is a reasonable chance that a product will cause serious health problems or death.
Was the TurboHawk Plus Also Recalled?
Medtronic also recalled its TurboHawk Plus system after the HawkOne action. According to MD+DI, as of Feb. 7 no injuries or deaths had been reported for it. Medtronic did not ask for the product to be returned or discarded.
What Does the Research Say About the HawkOne Tip Breakage Risk?
The research on HawkOne tip breakage includes Medtronic’s own figures. Medtronic said endovascular retrieval was needed for 0.033% of devices distributed and open surgical retrieval for 0.028%. Medtronic produced these numbers itself.
What Should I Do If I Had Complications After a HawkOne Procedure?
If you had complications after a HawkOne procedure, you can report the event to the FDA’s MedWatch program by calling 1-800-332-1088. MedWatch can send a reporting form to you on request.
How Can I Contact Medtronic About the HawkOne Recall?
You can contact Medtronic about the HawkOne recall through Medtronic Customer Service at 800-854-3570. The recall notice also lists a Medtronic field representative and the email address rs.recalls@medtronic.com for additional information.
References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190893
- https://www.mddionline.com/regulatory-quality/medtronic-recalls-turbohawk-due-to-hawkone-recall
- https://content.govdelivery.com/accounts/USFDA/bulletins/306def0
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=89229
- https://evtoday.com/news/medtronics-hawkone-directional-atherectomy-system-recalled
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190894
- https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall