Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The device failure can lead to life-threatening embolization, but the source does not report deaths or hospitalizations, only device defects.
Plain-English summary
Medtronic is recalling the HawkOne Directional Atherectomy System, a catheter-based medical device designed to remove arterial plaque in peripheral blood vessels. The recall encompasses 28,094 units distributed throughout the United States and over 30 countries globally. The affected devices carry catalog numbers H1-S and H1-S-INT and are manufactured by ev3 Inc.
The FDA classified this as a Class I recall after receiving reports of catheter tip damage during clinical use. In some cases, this damage resulted in tip detachment. A detached catheter tip can travel through the bloodstream and become lodged in a blood vessel—a process called embolization—which obstructs blood flow.
Healthcare providers and facilities using the HawkOne system should contact Medtronic for further guidance regarding affected devices.
The recalled product
- Product
- Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
- Manufacturer
- ev3 Inc.
- Affected units
- 28,094
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- H1-S - Irvine GTIN 00643169792319
- Galway GTIN 00643169968356. H1-S-INT
- Irvine GTIN 00643169728790
- Galway GTIN 00643169968530.
Distribution
Part of a larger recall action
This product is one of 2 recalled by ev3 Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · ev3 Inc.
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