FDA Device recall Z-2070-2021
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiol…
- FDA Device
- Class II
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiol… by Arrow International, citing marketed without a 510K.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2070-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-19 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arrow International |
| Distribution | US |
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
Marketed without a 510K
Identifiers
| code_info | Lot Numbers: 16F19J0109 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2070-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.