FDADecember 6, 2021device
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. The HawkOne cathet...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
What to do
FDA enforcement status: Terminated
Brands named
ev3
UPCs
00643169792319006431699683560064316972879000643169968530
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050...2024-12-10
- FDAMedtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.2022-02-04
- FDAMedtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.2022-02-04
- FDAMedtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-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. The HawkOne cathe...2021-12-06
- FDAPacific Xtreme (PTCA Balloon Dilation Catheter)2020-08-26
- FDAev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.2020-02-14
- FDAev3 Pipeline Flex Embolization Device. For neurological endovascular use.2020-02-14
- FDAev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.2018-08-10
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