FDA Device recall Z-2068-2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in el…
- FDA Device
- Class II
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in el… by Arrow International, citing marketed without a 510K.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2068-2021 |
| 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 Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - 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: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082 |
|---|
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-2068-2021%22
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