Stryker Neurovascular: Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 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-2175-2016

Recalling firm

Stryker Neurovascular

Product

Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 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:M0035443040 :  Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 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

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

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