Boston Scientific Corporation IceRod" Prostate Cryoablation Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IceRod" Prostate Cryoablation Kit
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226
Products Sold
UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226
Boston Scientific Corporation is recalling IceRod" Prostate Cryoablation Kit due to Complaint trend regarding needle shaft gas leaks.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaint trend regarding needle shaft gas leaks.
Recommended Action
Per FDA guidance
Customers will be sent a product advisory via overnight mail.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026