Device recall: GDC-10 360 SOFT 3mm x 6cm SR; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms…
Class II FDA enforcement event 69669. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
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 22 Oct 2014. 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 69669 has 5 product records. The first FDA enforcement report date is 10 Dec 2014. The record gives the status Terminated, with the termination date 12 Feb 2015.
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.
US Distribution to the states of: VA, NH, OH and TX.
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
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0478-2015 | GDC-10 360 SOFT 3mm x 6cm SR; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by… | 1 | Class II | Terminated | 10 Dec 2014 |
| Z-0479-2015 | GDC-10 360 10mm x 30cm SR; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional… | 1 unit | Class II | Terminated | 10 Dec 2014 |
| Z-0480-2015 | GDC-18 360 20mm x 33cm; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional… | 1 unit | Class II | Terminated | 10 Dec 2014 |
| Z-0481-2015 | Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular… | 1 unit | Class II | Terminated | 10 Dec 2014 |
| Z-0482-2015 | Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion. | 1 unit | Class II | Terminated | 10 Dec 2014 |
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 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 5
Official channels
- FDA enforcement report Z-0478-2015The 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.
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Cite this page
Recall Register. FDA enforcement event 69669. https://recallregister.com/fda/ii/69669/. 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:
US Distribution to the states of: VA, NH, OH and TX.
- What quantity of product is in FDA event 69669?
- The event has 5 product records. The first record gives this quantity:
1
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.