FDA Device recall Z-0147-2023
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP by Edwards Lifesciences, citing due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0147-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-06 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Reason
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Identifiers
| code_info | Fogarty Biliary Balloon Probes Model Number / UDI-DI Codes: 410235FP / 00690103205114 Lot Numbers: 63292039 63374470 63…Fogarty Biliary Balloon Probes Model Number / UDI-DI Codes: 410235FP / 00690103205114 Lot Numbers: 63292039 63374470 63412896 64180571 63750242 63872214 64049156 63996739 64063636 64180488 64205434 64220702 64285955 64332465 63301401 63676960 63669366 63420116 64285954 64297660 63484862 63669362 63996741 64014018 64231686 63797438 63488864 63435505 63475892 63560673 63544106 63600417 63611703 63623913 63633116 63669365 63669367 63611693 63687302 63724846 63712314 63734561 63738744 63850841 63755535 63772701 63872208 63913697 63891308 63954283 63914241 63942913 63995664 64052315 64052316 64085209 64085211 64098951 64110568 64124822 64193089 64238925 64264720 64252665 64274393 64357529 64347351 64354870 64393877 410405FP / 00690103205138 Lot Numbers: 63226302 63451847 64238928 63374472 63412898 63623906 63623905 63850845 63996749 64014019 64036646 64025083 64036645 64075497 64098950 64098952 64311169 63567220 63996747 63755536 63420118 63669363 64367703 63523275 63560687 64432720 634355 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2023%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.