Boston Scientific Corporation: IceRod" 1.5 i-Thaw" Cryoablation Needle

Is my product affected?

IceRod" 1.5 i-Thaw" Cryoablation Needle

• UPC 7290104830204

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

What happened

Boston Scientific Corporation is recalling 262 units of the IceRod 1.5 i-Thaw Cryoablation Needle due to a complaint trend regarding gas leaks in the needle shaft. The affected product was distributed nationwide and is identified by UPN FPRPR4009 and multiple batch numbers including U1362, U1217, U0957, U0282, U0283, U0087, T0819, T0392, and various A-series batches (A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, and A1329).

The source document does not specify a remedy or recommended action for consumers who may have this product.

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: 262 units Lot/code info: UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329

Source

Official record: FDA (Device enforcement) ↗

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

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