medical Class II Updated 2020-12-30

Boston Scientific Corporation recalls IceSphere" 1.5 Cryoablation Needle

Recalled Product

IceSphere" 1.5 Cryoablation Needle


Hazard / Issue

Complaint trend regarding needle shaft gas leaks.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185
View official government recall

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