Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Reported: July 29, 2020 Initiated: June 4, 2020 #Z-2676-2020
Product Description
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Reason for Recall
The needle surface deteriorated due to unexpected electrolysis during procedure.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 48 devices
- Distribution
- Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.. Recalled by Boston Scientific Corporation. Units affected: 48 devices.
Why was this product recalled? ▼
The needle surface deteriorated due to unexpected electrolysis during procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2676-2020.
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