Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-2168-2016)

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 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 Classification:

Class II

Date Initiated: June 6, 2016

Date Posted: July 20, 2016

Recall Number: Z-2168-2016

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: 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.

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