Boston Scientific Corporation: IceSeed" 1.5 90¿ Cryoablation Needle

Is my product affected?

IceSeed" 1.5 90¿ Cryoablation Needle

• UPC 7290104830235

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

What happened

Boston Scientific Corporation has recalled 788 units of IceSeed 1.5 90° Cryoablation Needles distributed nationwide. The needles were recalled due to a trend of complaints regarding gas leaks in the needle shaft. The affected units have UPN FPRPR3202 and UDI 7290104830235, with batch numbers including U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, and A0284.

The recall notice does not specify a remedy or recommended action for consumers who may have received these devices.

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: 788 units Lot/code info: UPN: FPRPR3202 UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235 Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284

Source

Official record: FDA (Device enforcement) ↗

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

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