Boston Scientific Corporation IcePearl" 2.1 CX Cryoablation Needle Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IcePearl" 2.1 CX Cryoablation Needle
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249
Products Sold
UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249
Boston Scientific Corporation is recalling IcePearl" 2.1 CX Cryoablation Needle 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