The Recall Desk
HighFDA (Devices)·Z-0671-2021·Announced 2020-12-30

Boston Scientific Recalls IceSphere 1.5 Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 245 units of IceSphere 1.5 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 hazard involves a functional defect (gas leak) in a medical device used for procedures, 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 245 units of the IceSphere 1.5 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 units identified by the UPN FPRPR3558 and UDI 7290104830938. Affected batch numbers include U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, and A1185.

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
IceSphere" 1.5 Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
245

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 (18)

  • UPN: FPRPR3558 UDIs: 7290104830938
  • 7290104830938
  • 7290104830938 Batch numbers: U1403
  • U1218
  • U0295
  • U0215
  • U0182
  • U0153
  • U0047
  • T0674
  • T0463
  • T0129
  • A7010
  • A6956
  • A6893
  • A6738
  • A2102
  • A1185

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 →