Boston Scientific Corporation: IceSphere" 1.5 Cryoablation Needle

Is my product affected?

IceSphere" 1.5 Cryoablation Needle

• UPC 7290104830938

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

What happened

Boston Scientific Corporation is recalling 245 units of the IceSphere 1.5 Cryoablation Needle due to a complaint trend involving gas leaks in the needle shaft. The affected product was distributed nationwide and is identified by UPN FPRPR3558 across multiple batch numbers (U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, and A1185).

The recall source does not specify a remedy or course of 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: 245 units Lot/code info: UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185

Source

Official record: FDA (Device enforcement) ↗

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

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