Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2177-2016 — Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

U.S. FDA — Device Enforcement · United States · 2016-06-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2177-2016
Date of alert
2016-06-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Neurovascular
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
18736425
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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