FDAAugust 26, 2020device
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
What to do
FDA enforcement status: Terminated
Brands named
ev3
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, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.2022-02-04
- FDAMedtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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
- FDAMedtronic 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...2021-12-06
- 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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