Agency classClass IIOur severity:High FDA (Devices)·Z-0675-2021·Announced 2020-12-30

Boston Scientific Recalls IceSeed Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 788 IceSeed 1.5 90° Cryoablation Needles nationwide because of 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 source text describes a functional defect (gas leaks) in a medical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 788 units of the IceSeed 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 specific units involved are identified by the Universal Product Number (UPN) FPRPR3202 and Universal Device Identifier (UDI) 7290104830235. The recall covers specific batch numbers including U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, and A0284.

Healthcare providers and facilities should check their inventory for these specific product codes and batch numbers. If the recalled product is found, it should be removed from use and returned to Boston Scientific Corporation according to their instructions.

The recalled product

Product: IceSeed" 1.5 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 788

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: FPRPR3202 UDIs: 7290104830235
7290104830235
7290104830235 Batch Numbers: U1165
U1166
U0911
U0912
U0397
U0381
U0368
T0791
T0790
T0465
T0464
T0050
T0051
A6981
A6980
A2129
A2128
A1635

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 →

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Same hazard · gas leak