Stryker Neurovascular: Medical Device Recall in 2014 - (Recall #: Z-0478-2015)

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:

GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable

Product Classification:

Class II

Date Initiated: October 22, 2014

Date Posted: December 10, 2014

Recall Number: Z-0478-2015

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

Code Information:

Model M003347306SRO, Lot number: 14467382; Exp. May 2014.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated