FDA Medical Device Recalls (openFDA)
Stryker Neurovascular: Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
- Recall number
- Z-2180-2016
- Recalling firm
- Stryker Neurovascular
- Product
- Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
- Status
- Terminated
- Initiated
- 2016-06-06
- Posted
- 2016-07-11
- Terminated
- 2017-03-03
- Reason
- Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
- Root cause
- Process change control
- Action
- Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
- Quantity
- 45,302 (8,188 in the U.S.) - total, all model numbers
- Distribution
- Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
- Lot, serial or model codes
- MODEL Number:M0035452040; Lot Number/Expiration Date: 18760131 31-Dec-18 18760129 31-Dec-18 18832208 31-Jan-19 18832819 31-Jan-19 18831597 31-Jan-19 18760132 31-Dec-18 18760130 31-Dec-18 18852438 28-Feb-19 18905625 31-Mar-19 18939389 31-Mar-19 19032961 30-Apr-19 19032868 30-Apr-19 19037908 31-May-19 18900809 28-Feb-19 18906580 28-Feb-19 18987592 30-Apr-19 19036655 31-May-19 18971469 30-Apr-19 18986652 30-Apr-19 18875322 28-Feb-19 19047456 31-May-19 18972020 30-Apr-19 18899967 28-Feb-19.
- 510(k) numbers
- ["K113412","K153658"]
- 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