Boston Scientific Corporation: Five IceRod" i-Thaw" Prostate Cryoablation Kit

Is my product affected?

Five IceRod" i-Thaw" Prostate Cryoablation Kit

• UPC 7290104830976

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

What happened

Boston Scientific Corporation is recalling 178 units of the IceRod i-Thaw Prostate Cryoablation Kit distributed nationwide due to complaints about needle shaft gas leaks. The affected product has UPN FPRPR3571 and batch numbers including U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, and A1252.

The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.

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: 178 units Lot/code info: UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252

Source

Official record: FDA (Device enforcement) ↗

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

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