Arrow Bipolar Balloon Electrode Catheter 5 Fr — Class II medical device recall Z-2070-2021
Ongoing recall by Arrow International Inc, reported 2021-07-21, distributed nationwide. Marketed without a 510K
| Recall number | Z-2070-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2021-05-19 |
| Classified | 2021-07-13 |
| Reported by FDA | 2021-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Lot numbers | 16F19J0109 |
Product
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Reason for recall
Marketed without a 510K
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-2070-2021. 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.