Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump — Class I medical device recall Z-0455-2023
Ongoing recall by ARROW INTERNATIONAL Inc., reported 2022-12-21. There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic
| Recall number | Z-0455-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2022-10-17 |
| Classified | 2022-12-15 |
| Reported by FDA | 2022-12-21 |
| Quantity | 1 units |
| Model numbers | IAP-05001 |
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Reason for recall
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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-0455-2023. 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.