Device recall: Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are…
Class II FDA enforcement event 74425. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this device recall on 6 Jun 2016. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Fremont, CA. FDA put the recall in Class II. FDA event 74425 has 28 product records. The first FDA enforcement report date is 20 Jul 2016. The record gives the status Terminated, with the termination date 3 Mar 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France,…
Recalling firm
The name is withheld, Fremont, CA.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
28 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2160-2016 | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2161-2016 | Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2162-2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2163-2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2164-2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2165-2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2166-2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2167-2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2168-2016 | 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. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2169-2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2170-2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2171-2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2172-2016 | Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2173-2016 | Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2174-2016 | Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2175-2016 | Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2176-2016 | Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| 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. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2178-2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2179-2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2180-2016 | 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. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2181-2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2182-2016 | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2183-2016 | 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. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2184-2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2185-2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2186-2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
| Z-2187-2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | 45,302 (8,188 in the U.S.) - total, all model numbers | Class II | Terminated | 20 Jul 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 28
Official channels
- FDA enforcement report Z-2160-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 74425. https://recallregister.com/fda/ii/74425/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France,…
- What quantity of product is in FDA event 74425?
- The event has 28 product records. The first record gives this quantity:
45,302 (8,188 in the U.S.) - total, all model numbers
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.