Boston Scientific Corporation: IceFORCE" 2.1 CX Cryoablation Needle

Is my product affected?

IceFORCE" 2.1 CX Cryoablation Needle

• UPC 7290104831027

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

What happened

Boston Scientific Corporation is recalling 75 units of the IceFORCE 2.1 CX Cryoablation Needle due to complaints about gas leaks in the needle shaft. The affected units were distributed nationwide and are identified by UPN FPRPR3604 and multiple batch numbers including U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, and A1203.

The source document does not specify a remedy or instructions 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: 75 units Lot/code info: UPN: FPRPR3604 UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027 Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203

Source

Official record: FDA (Device enforcement) ↗

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

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