Boston Scientific Corporation: IceRod" Prostate Cryoablation Kit

Is my product affected?

IceRod" Prostate Cryoablation Kit

• UPC 7290104830082

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

What happened

Boston Scientific Corporation has recalled 64 units of the IceRod Prostate Cryoablation Kit due to reports of gas leaks in the needle shaft. The affected units were distributed nationwide and are identified by UPN FPRPR3070 and specific batch numbers including U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, and A1226.

The recall notice does not specify what actions affected consumers or healthcare facilities should take in response to 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: 64 units Lot/code info: UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226

Source

Official record: FDA (Device enforcement) ↗

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

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