Boston Scientific Corporation: IceSphere" 1.5 S 90¿ Cryoablation Needle

Is my product affected?

IceSphere" 1.5 S 90¿ Cryoablation Needle

• UPC 7290104830556

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

What happened

Boston Scientific Corporation is recalling 729 units of the IceSphere 1.5 S 90° Cryoablation Needle distributed nationwide due to a complaint trend regarding gas leaks in the needle shaft. The affected product has UPN FPRPR3561 and was distributed in multiple batch numbers including U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, and A1364.

The source document does not specify a remedy or what action affected consumers 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: 729 units Lot/code info: UPN: FPRPR3561 UDIs: 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556 Batch Numbers: U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364

Source

Official record: FDA (Device enforcement) ↗

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

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