Home / Recalls / ev3, Inc. / Z-1552-2016

Z-1552-2016 Class II Terminated

Recalled by ev3, Inc. — Minneapolis, MN

Recall Details

Product Type: Devices
Report Date: May 4, 2016
Initiation Date: March 29, 2016
Termination Date: May 19, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 27 (25 US, 2 OUS)

Product Description

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

Reason for Recall

Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.

Distribution Pattern

US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE

Code Information

A213373 and A216702

Other recalls by ev3, Inc.

Z-0904-2025 Class II — Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0500 (December 10, 2024)
Z-0695-2022 Class I — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalo (February 4, 2022)
Z-0694-2022 Class I — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalo (February 4, 2022)
Z-0450-2022 Class I — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M- (December 6, 2021)
Z-0451-2022 Class I — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S- (December 6, 2021)
Z-3055-2020 Class II — Pacific Xtreme (PTCA Balloon Dilation Catheter) (August 26, 2020)
Z-2048-2016 Class II — EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene (May 23, 2016)
Z-0878-2015 Class II — ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx o (December 4, 2014)
Z-0879-2015 Class II — ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx o (December 4, 2014)
Z-1489-2014 Class II — ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: A (April 9, 2014)