Boston Scientific Recalls IceSphere 1.5 Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 39 IceSphere 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
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. The hazard involves a functional defect (gas leak) in a medical device where injury has not yet been reported, fitting the criteria for a risk-of-harm product without reported illness.
Plain-English summary
Boston Scientific Corporation is recalling 39 units of the IceSphere" 1.5 Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft. The affected products were distributed nationwide.
The specific units involved in this recall are identified by the following codes: UPN FPRPR3258, UDI 07290104830211, and Batch Number A0125. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- Product
- IceSphere" 1.5 Cryoablation Needle
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 39
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 (1)
- UPN: FPRPR3258 UDI: 07290104830211 Batch Number: A0125
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 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.
See all 37 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · gas leak
See all →- Severe
- High
- SeverePar Nado Alto Travel Trailers Recalled for Gas Leak Risk
NHTSA · 2025-10-31
- HighHeil Recalls Side Loader Garbage Trucks Due to Fuel Leak Risk
NHTSA · 2025-10-31
- High
Similar recalls
- HighBoston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceFORCE 2.1 CX Cryoablation Needles
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29
- ModerateIceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
FDA (Devices) · 2025-05-07
- HighBoston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29