Boston Scientific Corporation: IceFORCE" 2.1 CX Prostate Cryoablation Kit

Is my product affected?

IceFORCE" 2.1 CX Prostate Cryoablation Kit

• UPC 7290104831034

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling 85 units of the IceFORCE 2.1 CX Prostate Cryoablation Kit distributed nationwide due to a complaint trend regarding needle shaft gas leaks. The affected product has UPN FPRPR3605 and includes multiple batch numbers ranging from U1030 to A1291.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaint trend regarding needle shaft gas leaks.

Details from the source

Reason for recall: Complaint trend regarding needle shaft gas leaks. Distribution: Nationwide Quantity: 85 units Lot/code info: UPN: FPRPR3605 UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034 Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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