Z-2168-2016Class II

Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target...

Name: Z-2168-2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target...
Creator: Stryker Neurovascular
Published: 2016-06-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-06-06 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct... on 2016-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2168-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-06
Posted: 2016-07-11
Terminated: 2017-03-03
Recalling firm: Stryker Corp.
Product: Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Product code: HCG Device, Neurovascular Embolization
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: MODEL Number: M0035431510; Lot Number/Expiration Date: 18581295 30-Sep-18 18800256 31-Jan-19 18775373 31-Dec-18 18744204 30-Nov-18 18812788 31-Jan-19 18607578 30-Sep-18 18602655 30-Sep-18 19003141 30-Apr-19 18935435 31-Mar-19 18923481 31-Mar-19 18953907 31-Mar-19 18883412 28-Feb-19 18852906 28-Feb-19 19056331 31-May-19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2168-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2160-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2161-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2162-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2163-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2164-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2165-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2166-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2167-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2168-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2169-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2170-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2171-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2172-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2173-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2174-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2175-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2176-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2177-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2178-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2179-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2180-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2181-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2182-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2183-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2184-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2185-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2186-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2187-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11

Product code HCG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)