Stryker Neurovascular 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 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Stryker Neurovascular
Lot Codes / Batch Numbers
Model M003347306SRO, Lot number: 14467382, Exp. May 2014.
Products Sold
Model M003347306SRO, Lot number: 14467382; Exp. May 2014.
Stryker Neurovascular is recalling GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those i due to Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NH, OH, TX, VA
Page updated: Jan 13, 2026