Recall Z-1489-2014— Ev3, Inc.
Class II · Terminated
Class II FDA medical device recall by Ev3, Inc., initiated 2014-04-09, terminated 2014-10-06. It names 2 FDA 510(k) clearances: K103322, K082579. Product: 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. Reason: 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..
- Recalling firm
- Ev3, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-09
- Terminated
- 2014-10-06
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER
- K082579 — EVERCROSS .035 OTW PTA DILATATION CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.