Boston Scientific Corporation: Medical Device Recall in 2014 - (Recall #: Z-1164-2014)

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, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

Product Classification:

Class II

Date Initiated: March 3, 2014

Date Posted: March 19, 2014

Recall Number: Z-1164-2014

Event ID: 67658

Reason for Recall:

The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

Status: Terminated

Product Quantity: 7

Code Information:

2013040058

Distribution Pattern:

TX and Russia

Voluntary or Mandated:

Voluntary: Firm initiated