Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling 205 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
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 involves a medical device defect (surface deterioration) that poses a risk of harm during a surgical procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 205 units of the Ablation Galil Technology, IcePearl 2.1 CX 90 Cryoablation Needles. These prescription-only medical devices are intended for the cryoablative destruction of tissue during surgical procedures.
The recall was initiated because the needle surface deteriorated due to unexpected electrolysis during the procedure. The affected devices were distributed nationwide to specific U.S. states and to Canada.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- Product
- Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 205
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 (13)
- UPN: FPRPR3617
- GTIN: 07290104831072
- Batch: A0904
- A1085
- A1177
- A1178
- A6681
- A6682
- A6962
- A6963
- A6977
- A7113
- U0084
Distribution
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · device defect
See all →- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20