ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model:… recallZ-1552-2016 · ev3, Inc. · initiated Mar 29, 2016
Class II Terminated All recalls posted in April 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.
Recall details
- Recall number
- Z-1552-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 29, 2016
- Posted by the FDA
- Apr 22, 2016
- Recalling firm
- ev3, Inc.
- Quantity
- 27 (25 US, 2 OUS)
- Product code
- LIT
- FDA submissions
- K093286
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Product description
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Code information (models, lots, serial numbers)
A213373 and A216702
Other devices under the same FDA submission
12 devices cleared under K093286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PowerCross AB18W060100150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 recall1 report
- PowerCross AB18W025040150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W030100150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W040100150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W050040150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W060060150Covidien LP · Catheter, angioplasty, peripheral, transluminal2 reports
- PowerCross AB18W020100090Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W040040090Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W030060150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W030120150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W050150150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W050200150Covidien LP · Catheter, angioplasty, peripheral, transluminal1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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