News | Atherectomy Devices | March 09, 2022

Class I Recall on TurboHawk Plus Directional Atherectomy System by Medtronic

Recall is due to risk of tip damage during use

Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System due to design similarities shared with another device that was recently recalled for correction.

March 9, 2022 — Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System 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 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. 

For more information about this recall.

BACKGROUND: 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.

RECOMMENDATIONS: 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.
  • Customers who have questions about this recall should contact the company. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

For more information: www.fda.gov


Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now