Boston Scientific Corporation: Five IceSphere" Prostate Cryoablation Kit

Is my product affected?

Five IceSphere" Prostate Cryoablation Kit

• UPC 7290104830969

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

What happened

Boston Scientific Corporation is recalling 419 units of the IceSphere Prostate Cryoablation Kit nationwide due to a complaint trend involving gas leaks in the needle shaft. The affected kits have UPN FPRPR3570 and multiple batch numbers ranging from A1184 to U1402.

The recall record 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: 419 units Lot/code info: UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184

Source

Official record: FDA (Device enforcement) ↗

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

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