Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-2187-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Product Classification:

Class II

Date Initiated: June 6, 2016

Date Posted: July 20, 2016

Recall Number: Z-2187-2016

Event ID: 74425

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.

Status: Terminated

Product Quantity: 45,302 (8,188 in the U.S.) - total, all model numbers

Code Information:

MODEL Number:M0035453080; Lot Number/Expiration Date: 18459616 30-Jun-18 18532587 31-Aug-18 18837651 31-Jan-19 18827994 31-Jan-19 18906549 31-Mar-19 18985483 30-Apr-19 18935083 31-Mar-19 18984769 30-Apr-19 19056652 31-May-19 19034292 31-May-19 18875473 28-Feb-19.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated