Boston Scientific Recalls IceSeed MRI Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 1,526 IceSeed MRI 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 the hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 1,526 units of the IceSeed 1.5mm MRI 90mm 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 recall includes specific batch numbers and UDI codes listed in the official FDA record Z-0680-2021.
Healthcare providers and consumers should stop using the affected needles and contact Boston Scientific for further instructions or a replacement.
The recalled product
- Product
- IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,526
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: FPRPR3194 UDIs: 7290104830280
- 7290104830280
- 7290104830280 Batch Numbers: U1368
- U1367
- U1040
- U0396
- U0380
- U0375
- U0374
- U0242
- U0241
- T0532
- T0533
- T0531
- T0530
- T0444
- T0443
- T0442
- T0353
- T0354
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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