FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: IceRod" He-Thaw Prostate Cryoablation Kit
- Recall number
- Z-0693-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- IceRod" He-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
- 115 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411
- 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