Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-2183-2016)

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 2.5MM X 4CM MODEL Number:M0035452540 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-2183-2016
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:M0035452540; Lot Number/Expiration Date: 18440351 30-Jun-18 18539018 31-Aug-18 18439805 30-Jun-18 18519562 31-Jul-18 18468754 30-Jun-18 18922401 31-Mar-19 19060307 31-May-19 18970593 30-Apr-19 18898116 28-Feb-19 19034354 31-May-19 18875384 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