FDA Device recall Z-0687-2021
IceSeed" Prostate Cryoablation Kit
- FDA Device
- Class II
- completed
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of IceSeed" Prostate Cryoablation Kit by Boston Scientific, citing complaint trend regarding needle shaft gas leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0687-2021 |
| 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
IceSeed" Prostate Cryoablation Kit
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 72901…UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068 Batch Numbers: T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, A1684 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Other recalls by Boston Scientific
- NaviFlex LW Pusher
FDA Device · Class II · 2026-10-21 · Boston Scientific - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
FDA Device · Class I · 2026-09-30 · Boston Scientific - Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,…
FDA Device · Class II · 2026-09-23 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
FDA Device · Class II · 2026-09-09 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0687-2021%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.