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U.S. Department of Health and Human Services

Class 2 Device Recall Ev3, Inc. (Medtronic)

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  Class 2 Device Recall Ev3, Inc. (Medtronic) see related information
Date Initiated by Firm March 29, 2016
Date Posted April 22, 2016
Recall Status1 Terminated 3 on May 19, 2017
Recall Number Z-1552-2016
Recall Event ID 73706
510(K)Number K093286  
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
Product ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Code Information A213373 and A216702
Recalling Firm/
Manufacturer		 ev3, Inc.
3033 Campus Drive
Minneapolis MN 55441
For Additional Information Contact
763-398-7000
Manufacturer 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.
FDA Determined
Cause 2		 Labeling False and Misleading
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.
Quantity in Commerce 27 (25 US, 2 OUS)
Distribution US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = EV3 INC
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