FDA Device recall Z-0120-2016
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent…
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent… by Micro Therapeutics, citing the firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0120-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-04 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Micro Therapeutics |
| Distribution | IL, KY, MD, MO, OR, TN, UT, VA, WI |
Product
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
Reason
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
Identifiers
| code_info | Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18V…Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316 Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0120-2016%22
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