FDA Device recall Z-1528-2020
ev3 Pipeline Flex Embolization Device with Shield Technology
- 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 with Shield Technology 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-1528-2020 |
| 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 with Shield Technology. Sold OUS. 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: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918…Lots: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918665 A918667 A918668 A920902 A922597 A922598 A922599 A922600 A922601 A922687 A922688 A922690 A922691 A922692 A922693 A922694 A922695 A922697 A922698 A922699 A925289 A925290 A925291 A925292 A925293 A925295 A925296 A925297 A925298 A925299 A925300 A925913 A925914 A925915 A925917 A925918 A925920 A925923 A925926 A925928 A925929 A925930 A925931 A926530 A926531 A926532 A926533 A926536 A926537 A926538 A926625 A926626 A926627 A926628 A926629 A927960 A927961 A927962 A931450 A931451 A931452 A931453 A931454 A931455 A931456 A931458 A931459 A931460 A934805 A934806 A934807 A934808 A934809 A935480 A935481 A935482 A935483 A935484 A935486 A935487 A935900 A935901 A935902 A935903 A935904 A935912 A935913 A935914 A935916 A935917 A936513 A936514 A936515 A936516 A936517 A936518 A936519 A936520 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-1528-2020%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.