Boston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration
Boston Scientific is recalling 79 IceFORCE 2.1 CX Prostate Kits because needle surfaces 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 a structural defect (needle surface deterioration) in a surgical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 79 units of the Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System. The recall involves Galil Medicals 2.1 CX Cryoablation Needles, which are prescription-only devices intended for the cryoablative destruction of tissue during surgical procedures.
The recall was initiated because the needle surface deteriorated due to unexpected electrolysis during the procedure. The affected devices were distributed nationwide to 40 states and the District of Columbia, as well as to Canada. Specific batch codes associated with the recall include A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, and T0153.
Healthcare providers and patients who have used or possess these devices should contact Boston Scientific Corporation for further instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, 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
- 79
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 (15)
- UPN: FPRPR3605
- GTIN: 7290104831034
- Batch: A1105
- A1193
- A1291
- A1435
- A1550
- A1565
- A1776
- A1781
- A6758
- A6930
- A7062
- A7061
- T0153
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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