Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging
Galil Medical is recalling 49 Visual-ICE Cryoablation Systems because the needles may clog or fail to freeze tissue adequately.
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 involves a medical device with a functional defect (inadequate freezing) that poses a risk of harm to patients, 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
Galil Medical, Inc. is recalling 49 Visual-ICE Cryoablation Systems (Model FPRCH6000). These mobile console systems are intended for cryoablative tissue destruction using minimally invasive procedures. The systems use high-pressure argon gas to induce tissue freezing and helium gas or I-Thaw technology for thawing.
The recall is being issued because the Visual-ICE systems utilizing IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles may experience issues with needle clogging and/or inadequate freezing performance. The affected units were distributed in 22 U.S. states, Puerto Rico, and several international locations including Argentina, Canada, Taiwan, and the United Kingdom.
Healthcare facilities and users should stop using the affected systems and contact Galil Medical for instructions on corrective actions. The specific serial numbers and PM Kit numbers for the 49 affected units are listed in the official FDA recall notice.
The recalled product
- Product
- Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control…
- Manufacturer
- Galil Medical, Inc.
- Affected units
- 49
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)
- System Serial Number / PM Kit #: VL0031 / PM0506M
- VL0036 / PM0546M
- VL0067 / PM0515M
- VL0069 / PM0565M
- VL0075 / PM0532M
- VL0079 / PM0539M
- VL0082 / PM0491M
- VL0085 / PM0486M
- VL0086 / PM0499M
- VL0088 / PM0489M
- VL0090 / PM0513M
- VL0092 / PM0548M
- VL0093 / PM0544M
- VL0094 / PM0520M
- VL0100 / PM0516M
- VL0102 / PM0529M
- VL0105 / PM0560M
- VL0112 / PM0542M
- VL0115 / PM0525M
- VL0136 / PM0561M
Distribution
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