FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: IceRod" i-Thaw" Prostate Cryoablation Kit
- Recall number
- Z-0686-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- IceRod" i-Thaw" Prostate Cryoablation Kit
- Status
- Completed
- Initiated
- 2020-11-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- Complaint trend regarding needle shaft gas leaks.
- Root cause
- Under Investigation by firm
- Action
- Customers will be sent a product advisory via overnight mail.
- Quantity
- 947 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UPN: FPRPR3572 UDIs: 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983 Batch Numbers: U1423, U1422, U1329, U1227, U1091, U1128, U1127, U1090, U0976, U1011, U0919, U0917, U0868, U0869, U0738, U0739, U0403, U0404, U0297, U0296, U0256, U0255, U0217, U0218, U0034, U0176, U0033, U0032, U0016, U0040, U0015, T0759, T0758, T0731, T0651, T0634, T0524, T0507, T0502, T0470, T0429, T0401, T0391, T0372, T0351, T0319, T0306, T0281, T0271, T0247, T0198, T0189, T0161, T0084, T0074, T0008, A7231, A7212, A7206, A7188, A7040, A7018, A6983, A6898, A6886, A6878, A6867, A6864, A6843, A6824, A6787, A6718, A6687, A6671, A6663, A6646, A2138, A2124, A2100, A2099, A2082, A2053, A2013, A2001, A1994, A1975, A1945, A1892, A1761, A1748, A1688, A1685, A1612, A1596, A1519, A1502, A1497, A1479, A1447, A1424, A1405, A1378, A1377, A1356, A1347, A1340, A1320, A1227, A1218, A1202, A1187
- 510(k) numbers
- ["K060390"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28