FDA Medical Device Recalls (openFDA)
Stryker Neurovascular: GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients 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 number
- Z-1516-2016
- Recalling firm
- Stryker Neurovascular
- Product
- GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients 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.
- Status
- Terminated
- Initiated
- 2016-03-21
- Posted
- not on file
- Terminated
- 2016-07-05
- Reason
- The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
- Root cause
- Under Investigation by firm
- Action
- The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to. Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
- Quantity
- 316 total, both models
- Distribution
- Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
- Lot, serial or model codes
- Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.
- 510(k) numbers
- ["K042539"]
- PMA numbers
- not on file
- Product code
- HCG
- Firm FEI
- 3008853977
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28