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

Is my product affected?

IceSphere" 1.5 CX 90¿ Cryoablation Needle

• UPC 7290104831133

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

What happened

Boston Scientific Corporation is recalling the IceSphere 1.5 CX 90° Cryoablation Needle due to a complaint trend regarding needle shaft gas leaks. The affected product has UPN FPRPR3573 with UDI 7290104831133, and approximately 6,363 units were distributed nationwide.

The source document does not specify a remedy or what affected consumers should do regarding 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: 6,363 units Lot/code info: UPN: FPRPR3573 UDIs: 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 729010483

Source

Official record: FDA (Device enforcement) ↗

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

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