Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter Recalled by Ev3, Inc. Due to Covidien is recalling 2 production lots of EverCross...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ev3, Inc. directly.
Affected Products
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
Quantity: 39 units (31 OUS, 8 US)
Why Was This 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.
Where Was This Sold?
This product was distributed to 6 states: IN, NY, NC, OK, TX, WV
About Ev3, Inc.
Ev3, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report