The Recall Desk
Agency classClass IIOur severity:HighFDA (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.

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 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
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 →

Related recalls

Same manufacturer · Boston Scientific Corporation

See all →

Same hazard · gas leak

See all →

Similar recalls