Boston Scientific Recalls IceForce 2.1 CX Cryoablation Needles
Boston Scientific is recalling 656 IceForce 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves device malfunction (surface deterioration) during a surgical procedure, which poses a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 656 units of the Ablation Galil Technology, IceForce 2.1 CX 90 Cryoablation Needles. These prescription-only medical devices are intended for the cryoablative destruction of tissue during surgical procedures.
The recall was initiated because the needle surface deteriorated due to unexpected electrolysis occurring during the procedure. The affected devices were distributed nationwide to numerous U.S. states and to Canada.
Healthcare providers and patients should stop using these specific devices. The recall includes specific batch numbers and product codes listed in the official FDA notice. Users should contact Boston Scientific or their supplier for further instructions on how to return or replace the affected needles.
The recalled product
- Product
- Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 656
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN: FPRPR3618
- GTIN: 07290104831089
- Batch: X2073
- X6812
- A0815
- A0994
- A1044
- A1046
- A1188
- A1189
- A1544
- A1545
- A1774
- A1775
- A2029
- A2030
- A6677
- A6678
- A7032
- A7033
Distribution
Part of a larger recall action
This product is one of 10 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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