ev3, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1552-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

Product Classification:

Class II

Date Initiated: March 29, 2016

Date Posted: May 4, 2016

Recall Number: Z-1552-2016

Event ID: 73706

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.

Status: Terminated

Product Quantity: 27 (25 US, 2 OUS)

Code Information:

A213373 and A216702

Distribution Pattern:

US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE

Voluntary or Mandated:

Voluntary: Firm initiated