High FDA (Devices)·Z-0681-2021·Announced 2020-12-30

Boston Scientific Recalls IceSeed MRI Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 627 IceSeed 1.5 MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

What this means for you

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 627 units of the IceSeed 1.5 MRI Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft.

The affected devices were distributed nationwide. The recall includes specific units identified by the Universal Product Number (UPN) FPRPR3192 and various batch numbers, including U1438, U1439, U0962, and others listed in the agency documentation.

Healthcare providers and patients who have used or possess these specific devices should contact Boston Scientific Corporation for further instructions on the recall and potential replacement or repair options.

The recalled product

Product: IceSeed" 1.5 MRI Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 627

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: FPRPR3192 UDIs: 7290104830266
7290104830266
7290104830266 Batch Numbers: U1438
U1439
U0962
U0961
U0437
U0378
T0697
T0688
T0388
T0387
A7150
A7149
A2018
A2017
A1711
A1710
A1689
A1403

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 →

Same manufacturer · Boston Scientific Corporation

See all →

High
Boston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
High
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
High
Boston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
High
Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
Severe
Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12

Same hazard · gas leak