FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: IceSeed" 1.5 90 Cryoablation Needle
- Recall number
- Z-0675-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- IceSeed" 1.5 90 Cryoablation Needle
- 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
- 788 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UPN: FPRPR3202 UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235 Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284
- 510(k) numbers
- ["K060144"]
- 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