Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J — Class II medical device recall Z-0716-2020
Terminated recall by Arrow International Inc, reported 2019-12-25, distributed nationwide. Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing
| Recall number | Z-0716-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2019-12-19 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1 units |
| Reason classes | packaging |
| Lot numbers | 16F19H0093 |
| Model numbers | AI-07130-J |
Product
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Reason for recall
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
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-0716-2020. 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.