Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:26088
Brand Name:Cryotherapy Needles
Model:IceForce 2.1 CX and IcePearl 2.1 CX Cryoablation Needles
Affected:
Software version:
Recalling Organisation:Urotech Limited
706 Wright Road
RD 4
Katikati
Tauranga 3181
Contact Information:
Manufacturer:Galil Medical
Issue:Following one report of a serious injury in a patient during a procedure due to a high-pressure gas leak from a needle during the electrical thawing operation. The initial investigation has found that the needle surface deteriorated due to unexpected electrolysis during the procedure. The duration of the electrolysis was long enough to cause a perforation in the shaft wall.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:6/6/2020
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