Boston Scientific Corporation: IceSeed" Prostate Cryoablation Kit

Is my product affected?

IceSeed" Prostate Cryoablation Kit

• UPC 7290104830068

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

What happened

Boston Scientific Corporation is recalling the IceSeed Prostate Cryoablation Kit due to a trend of complaints involving gas leaks from the needle shaft. The recall affects 52 units distributed nationwide, identified by UPN FPRPR3008 and specific batch numbers including T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, and A1684.

The recall record does not specify a remedy or instructions for what affected consumers should do.

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: 52 units Lot/code info: UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068 Batch Numbers: T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, A1684

Source

Official record: FDA (Device enforcement) ↗

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

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