Boston Scientific Corporation: Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Is my product affected?

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

• UPC 7290104831058

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

What happened

Boston Scientific Corporation is recalling 140 units of the IceFORCE 2.1 CX Prostate Cryoablation Kit distributed nationwide due to a complaint trend involving needle shaft gas leaks. The affected devices have UPN FPRPR3607 and multiple batch numbers ranging from A1194 to U1303.

The source does not specify a remedy or corrective 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: 140 units Lot/code info: UPN: FPRPR3607 UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058 Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194

Source

Official record: FDA (Device enforcement) ↗

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

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