FDA Device recall Z-1527-2020
ev3 Pipeline Flex Embolization Device
- FDA Device
- Class I
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class I recall of ev3 Pipeline Flex Embolization Device by Micro Therapeutics, citing embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1527-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-02-14 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Micro Therapeutics |
| Distribution | US |
Product
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Reason
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
Identifiers
| code_info | Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921…Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921354 A921355 A921356 A921357 A921358 A921359 A921360 A921361 A921362 A921363 A922016 A922017 A922018 A922020 A922021 A922022 A922480 A922481 A922483 A922484 A922571 A922572 A922575 A923951 A923956 A923959 A923960 A923963 A923967 A923968 A923969 A924193 A924194 A924197 A924198 A924199 A924638 A924640 A924641 A924642 A924643 A924644 A924645 A924646 A924647 A924648 A924650 A927827 A927828 A927829 A927830 A927831 A927832 A927833 A927834 A927835 A927836 A927837 A927838 A927839 A927840 A927841 A927842 A927843 A927844 A927845 A927847 A927848 A929704 A929705 A929706 A929707 A929708 A929710 A929711 A929713 A929714 A929716 A929717 A929893 A929894 A929896 A929897 A929898 A929901 A929902 A929903 A929904 A929906 A929907 A932604 A932605 A932607 A932609 A932610 A932611 A932612 A932613 A93 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1527-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.