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Terminated

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

FDA Recall Z-1552-2016 · Posted 2016-04-22

Recalling Firmev3, Inc.
Recall StatusTerminated
Product CodeLIT
Date Initiated2016-03-29
Date Terminated2017-05-19
Product Quantity27 (25 US, 2 OUS)

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.

Firm Action

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.

Root Cause

Labeling False and Misleading

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093286POWERCROSS .018 OTW PTA DILATION CATHETEREv3, Inc. · 2009-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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