Boston Scientific Corporation: Medical Device Recall in 2014 - (Recall #: Z-0969-2014)

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:

Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.

Product Classification:

Class II

Date Initiated: February 4, 2014

Date Posted: February 19, 2014

Recall Number: Z-0969-2014

Event ID: 67437

Reason for Recall:

Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T

Status: Terminated

Product Quantity: 35 for both products.

Code Information:

16397693

Distribution Pattern:

US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.

Voluntary or Mandated:

Voluntary: Firm initiated