ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x… recallZ-1489-2014 · Ev3, Inc. · initiated Apr 9, 2014
Class II Terminated All recalls posted in April 2014
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
Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
FDA root cause category: Labeling Change Control
What the company is doing
Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.
Recall details
- Recall number
- Z-1489-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 9, 2014
- Posted by the FDA
- Apr 23, 2014
- Recalling firm
- Ev3, Inc.
- Quantity
- 39 units (31 OUS, 8 US)
- Product code
- DQY
- FDA submissions
- K082579, K103322
- Distribution
- Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
Product description
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
Code information (models, lots, serial numbers)
AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16
Other devices under the same FDA submission
43 devices cleared under K082579, K103322 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EverCross™ AB35W06040080Ev3, Inc · Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W06200135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W12060080Ev3, Inc · Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W05040135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W05100135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W06120135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W09040080Ev3, Inc · Catheter, angioplasty, peripheral, transluminal1 death3 reports
- EverCross™ AB35W04200135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W05040080Ev3, Inc · Catheter, angioplasty, peripheral, transluminal1 death2 reports
- EverCross™ AB35W05150135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06030135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06040135Ev3, Inc · Catheter, angioplasty, peripheral, transluminal2 reports
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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