CLASS II Device recall · Reported 20 Jul 2016 · FDA Enforcement Report

Target Detachable Coils: Target Helical Nano recalled

Stryker Neurovascular is recalling Target Detachable Coils: Target Helical Nano, distributed nationwide in the US. The recall was initiated on 6 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMODEL Number:M0035452040; Lot Number/Expiration Date: 18760131 31-Dec-18 18760129 31-Dec-18 18832208 31-Jan-19 18832819 31-Jan-19 18831597 31-Jan-19 18760132 31-Dec-18 18760130 31-Dec-18 18852438 28-Feb-19 18905625 31-Mar-19 18939389 31-Mar-19 19032961 30-Apr-19 19032868 30-Apr-19 19037908 31-May-19 18900809 28-Feb-19 18906580 28-Feb-19 18987592 30-Apr-19 19036655 31-May-19 18971469 30-Apr-19 18986652 30-Apr-19 18875322 28-Feb-19 19047456 31-May-19 18972020 30-Apr-19 18899967 28-Feb-19.

Quantity recalled45,302 (8,188 in the U.S.) - total, all model numbers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2180-2016
FDA event ID: 74425
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2016
FDA classified: 11 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Heart & Vascular Devices

Timeline

6 Jun 2016	Recall initiated by company
11 Jul 2016	Classified by FDA	+35 days
20 Jul 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Where it was distributed

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.

Nationwide

Stores named: Target

Questions about this recall

Is Target Detachable Coils: Target Helical Nano recalled?

Yes. Stryker Neurovascular recalled Target Detachable Coils: Target Helical Nano on 6 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2180-2016.

Why was it recalled?

Which lots are affected?

MODEL Number:M0035452040; Lot Number/Expiration Date: 18760131 31-Dec-18 18760129 31-Dec-18 18832208 31-Jan-19 18832819 31-Jan-19 18831597 31-Jan-19 18760132 31-Dec-18 18760130 31-Dec-18 18852438 28-Feb-19 18905625 31-Mar-19 18939389 31-Mar-19 19032961 30-Apr-19 19032868 30-Apr-19 19037908 31-May-19 18900809 28-Feb-19 18906580 28-Feb-19 18987592 30-Apr-19 19036655 31-May-19 18971469 30-Apr-19 18986652 30-Apr-19 18875322 28-Feb-19 19047456 31-May-19 18972020 30-Apr-19 18899967 28-Feb-19.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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