Reported Jul 20, 2016 · Terminated
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils…
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- Target Detachable CoilsTARGET HELICAL NANO 1.5
- MM X 3 CM MODEL NumberM0035431530
- NeurologyTarget Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels
- Lot codes and dates
- MODEL NumberM0035431530:
- Lot Number/Expiration Date
172 of 172 codes
1875825431-Dec-181868525830-Nov-181865128531-Oct-181863756431-Oct-181842687631-May-181880274831-Jan-191875845931-Dec-181870948630-Nov-181863750631-Oct-181855166231-Aug-181855189431-Aug-181855177831-Aug-181850352931-Jul-181846647130-Jun-181884196431-Jan-191882960131-Jan-191875804931-Dec-181876756931-Dec-181868554830-Nov-181865122731-Oct-181855160431-Aug-181883063031-Jan-191884369828-Feb-191884283131-Jan-191863739031-Oct-181859250030-Sep-181855724031-Aug-181862728131-Oct-181877636331-Dec-181876707031-Dec-18
- Amount recalled
- 45,302 (8,188 in the U.S.) - total, all model numbers
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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