Boston Scientific Corporation: IceSeed" Prostate Cryoablation Kit

Is my product affected?

IceSeed" Prostate Cryoablation Kit

• UPC 7290104830075

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

What happened

Boston Scientific Corporation is recalling 211 units of the IceSeed Prostate Cryoablation Kit nationwide due to a complaint trend involving gas leaks in the needle shaft. The affected units have UPN FPRPR4518 and were distributed across multiple batch numbers ranging from A1225 to U1262.

The source document does not specify a remedy or corrective action for consumers who may have received affected units.

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: 211 units Lot/code info: UPN: FPRPR4518 UDIs: 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075 Batch Numbers: U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225

Source

Official record: FDA (Device enforcement) ↗

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

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