Ev3, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1489-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 9, 2014

Date Posted: April 30, 2014

Recall Number: Z-1489-2014

Event ID: 68034

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.

Status: Terminated

Product Quantity: 39 units (31 OUS, 8 US)

Code Information:

AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated