FDA Device recall Z-0661-2021
IcePearl" 2.1 CX Cryoablation Needle
- FDA Device
- Class II
- completed
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of IcePearl" 2.1 CX Cryoablation Needle by Boston Scientific, citing complaint trend regarding needle shaft gas leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0661-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-11-18 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
IcePearl" 2.1 CX Cryoablation Needle
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 72901…UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0661-2021%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.