Boston Scientific Corporation: IceSeed" 1.5 MRI Cryoablation Needle

Is my product affected?

IceSeed" 1.5 MRI Cryoablation Needle

• UPC 7290104830266

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

What happened

Boston Scientific Corporation is recalling 627 units of the IceSeed 1.5 MRI Cryoablation Needle that were distributed nationwide. The recall was initiated due to a complaint trend regarding gas leaks in the needle shaft.

The recall affects units with UPN FPRPR3192 and the specified batch numbers ranging from A0896 to U1439. The source document does not specify a remedy 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: 627 units Lot/code info: UPN: FPRPR3192 UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266 Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897

Source

Official record: FDA (Device enforcement) ↗

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

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