Agency classClass IIOur severity:High FDA (Devices)·Z-0663-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 18,731 IceRod 1.5 CX 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 hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 18,731 units of the IceRod 1.5 CX 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 recall is classified as Class II by the U.S. Food and Drug Administration. The specific batch numbers and Unique Device Identifiers (UDIs) for the affected units are listed in the official recall documentation. No specific dates of manufacture or distribution are provided in the source text.

Healthcare providers and patients should check their inventory and records for the specific batch numbers and UDIs associated with this recall. If a device is found to be affected, it should be removed from use and returned to Boston Scientific Corporation according to their instructions.

The recalled product

Product: IceRod" 1.5 CX 90¿ Cryoablation Needle¿
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
device-malfunction
Affected units: 18,731

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: FPRPR3533 UDIs: 7290104830587
7290104830587
7290104830587 Batch Numbers: U1450
U1445
U1437
U1436
U1419
U1415
U1413
U1411
U1412
U1414
U1417
U1418
U1416
U1408
U1410
U1409
U1405
U1382

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