Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling 18,440 IceFORCE 2.1 CX 90 Needle 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 surface deterioration of a surgical instrument, which poses a risk of harm during a procedure, but the source text does not report any specific injuries, hospitalizations, or deaths, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 18,440 units of the Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle. These prescription-only medical devices are intended for the cryoablative destruction of tissue during surgical procedures. The recall is being conducted because the needle surface deteriorated due to unexpected electrolysis during the procedure.
The affected devices were distributed nationwide to 48 states, the District of Columbia, and Canada. The recall includes specific batch numbers, which are listed in the official FDA record. No specific dates of distribution or sales are provided in the source text.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for instructions on how to return or replace them. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, 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
- 18,440
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: FPRPR3602
- GTIN: 7290104831003
- Batch: A0754
- A0755
- A0758
- A0759
- A0770
- A0771
- A0782
- A0783
- A0788
- A0789
- A0794
- A0795
- A0803
- A0804
- A0827
- A0828
- A0833
- A0834
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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