Stryker Neurovascular: Medical Device Recall in 2014 - (Recall #: Z-0482-2015)

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:

Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.

Product Classification:

Class II

Date Initiated: October 22, 2014

Date Posted: December 10, 2014

Recall Number: Z-0482-2015

Event ID: 69669

Reason for Recall:

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.

Distribution Pattern:

US Distribution to the states of: VA, NH, OH and TX.

Voluntary or Mandated:

Voluntary: Firm initiated