| Class 2 Device Recall Ev3, Inc. (Medtronic) | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LIT
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