Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 93 units of IceRod 1.5 90° 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 and involves a functional defect (gas leaks) in a medical 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 93 units of the IceRod 1.5 90° 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 recalled products are identified by the following codes: UPN FPRPR3204, UDI 7290104830242, and batch numbers U0495, U0498, U0496, U0497, U0420, A0902, and A0903. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected needles and contact Boston Scientific for further instructions on the recall process.
The recalled product
- Product
- IceRod" 1.5 90¿ Cryoablation Needle
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 93
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 (9)
- UPN: FPRPR3204 UDIs: 7290104830242
- 7290104830242
- 7290104830242 Batch Numbers: U0495
- U0498
- U0496
- U0497
- U0420
- A0902
- A0903
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.
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