FDA Device recall Z-2955-2024
Impella CP Smart Assist Set, JP
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of Impella CP Smart Assist Set, JP by Abiomed, citing A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2955-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-05 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | US |
Product
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Reason
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Identifiers
| code_info | Product Code: 0048-0024-JP; UDI-DI: 00813502011609; Serial Numbers: 353552 376694 381128 383037 383039 383040 383041 38…Product Code: 0048-0024-JP; UDI-DI: 00813502011609; Serial Numbers: 353552 376694 381128 383037 383039 383040 383041 383042 383043 383044 383045 383046 382465 382467 382468 382469 382470 382472 382136 382138 381247A 379963A 382779 382780 382781 375895 383330 382466 382782 382784 382787 384202 384201 383804 383806 382783 383808 383809 385265 385266 385272 386835 383810 373929 381881 385218 385220 385223 385270 385219 371886 375943 382788 382789 382790 382792 382793 372575 375208 382794 382795 382796 385724 385726 385727 385728 385721 385723 374156 378689 384134 384138 384139 385526 385528 384132 376414 381123 381859 382132 381869A 382785 384140 385530 385531 382786 385532 384207 384210 384684 384687 384688 384689 384128 384692 384126 375207 382130 383813 385527 385529 385534 384123 374157 369021 379105 383811 384133 385729 385730 384693 386201 386202 386207 386209 384983 384981 384980 386032 387077 387085 370796 383812 385525 386204 386210 386033 384204 384205 384209 384685 387078 38707 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2955-2024%22
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