Impella CP Smart Assist Set — Class II medical device recall Z-2969-2024
Ongoing recall by Abiomed, Inc., reported 2024-09-11, distributed nationwide. A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during
| Recall number | Z-2969-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2024-08-05 |
| Classified | 2024-09-04 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, DE, DK, ES, FI, FR, GB, HK, HR, IE, IL, IN, IT, JP, KW, LU, MX, MY, NL, NO, PA, PL, RS, SA, SE, SG, SI, TW |
| Quantity | 39 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813502012873 |
| Lot numbers | 2023251705, 2023251861, 2023251862, 2023251869, 2023251872, 2023251874, 2023251876, 2023251879, 2023251881, 2023251902, 2023283187, 2023283192, 2023283194, 2023283196, 2023283200, 2023283208, 2023283216, 2024305462, 2024305463, 2024305465, 2024305466, 2024305467, 2024308137, 2024308138, 2024308139, 2024308141, 2024308143, 2024308144, 2024308146, 2024308148, 2024308149, 2024308150, 2024308159, 2024308160, 2024308162, 2025501277, 2025501292, 2025501297, 2025501301 |
| Serial numbers | 385941, 385942, 385943, 385944, 385945, 385946, 385947, 385948, 385949, 385950, 392848, 392849, 392851, 392852, 392853, 392854, 392855, 392878, 392879, 427386, 427387, 427388, 430867, 430868, 430869 and 14 more |
Product
Impella CP Smart Assist Set; Product Code: 1000402;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2969-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.