FDA Device recall Z-0146-2023
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arteri…
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arteri… 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-0146-2023 |
| 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 Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
Reason
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Identifiers
| code_info | Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 6332…Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 63325817 63412990 64049166 64052416 64320468 64311217 64286041 64075556 64085285 64124889 64180619 63914203 63967960 63266275 63281593 63449645 63560630 63612077 63626926 63738860 63735762 63750304 63772968 63724845 63914201 63892007 63967950 63990050 64027881 64036551 64052415 64063487 64124888 64173669 64180620 64180548 64332505 64344742 63907174 64099010 64099008 63420190 63435603 63476159 63511721 63600508 63611742 63669399 63750303 63735818 63850952 63907175 63944429 63984736 63944467 63907167 64014108 63995701 64036698 64075555 64180549 64173668 64110676 64205522 64220842 64252735 64231811 64231810 64264792 64274428 64297806 64297810 64321021 64321020 63281591 63375216 63420189 63464807 63501933 63560629 63634785 63612076 63914359 64193163 64266393 64239056 63375217 64059266 64252737 63735761 63412989 63600507 63633312 63990049 64193162 64205539 64383524 64394451 636 |
|---|
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-0146-2023%22
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