medical Class II Updated 2020-12-30

Boston Scientific Corporation recalls IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

Recalled Product

IceFORCE" 2.1 CX L 90¿ Cryoablation Needle


Hazard / Issue

Complaint trend regarding needle shaft gas leaks.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: FPRPR3618 UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089 Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189
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