Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling IcePearl 2.0 CX 90 Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the hazard involves a functional defect (surface deterioration) in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling 7,536 units of the Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle. 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 during the procedure. The affected devices were distributed nationwide to 40 U.S. states and the District of Columbia, as well as to Canada.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions on how to return or replace the product.
The recalled product
- Product
- Ablation Galil Technology, IcePearl 2.0 CX 90 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
- 7,536
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: FPRPR3601
- GTIN: 07290104830990
- Batch numbers: A0735
- A0736
- A0749
- A0750
- A0798
- A0799
- A0817
- A0818
- A0840
- A0841
- A0874
- A0875
- A0888
- A0889
- A0898
- A0899
- A0945
- A0946
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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