The Recall Desk
HighFDA (Devices)·Z-0662-2021·Announced 2020-12-30

Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 261 IcePearl 2.1 CX L 90° 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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm if the device fails during a procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 261 units of the IcePearl 2.1 CX L 90° Cryoablation Needle. The recall is being conducted due to a complaint trend regarding needle shaft gas leaks. The affected products were distributed nationwide.

The recall involves specific units identified by the Universal Product Number (UPN) FPRPR3617 and the Universal Device Identifier (UDI) 7290104831072. The affected batch numbers include U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, and A1177.

Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Boston Scientific Corporation for instructions on how to return the affected devices.

The recalled product

Product
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
261

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: FPRPR3617 UDIs: 7290104831072
  • 7290104831072
  • 7290104831072 Batch numbers: U1310
  • U1309
  • U1306
  • U1305
  • X0828
  • U0727
  • U0728
  • U0641
  • U0640
  • U0587
  • U0586
  • U0585
  • U0084
  • A7113
  • A6977
  • A6963
  • A6962
  • A6681

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 →