Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit — Class I medical device recall Z-1880-2024
Ongoing recall by ARROW INTERNATIONAL Inc., reported 2024-06-12, distributed nationwide. Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly,
| Recall number | Z-1880-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2024-04-29 |
| Classified | 2024-06-03 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE |
| Quantity | 3,138 units |
| UPC / GTIN / UDI-DI | 10801902161922, 10801902172850, 10801902172874, 10801902182019 |
| Model numbers | IAB-05830-U, IAB-05840-U |
Product
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Reason for recall
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
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-1880-2024. 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.