Z-0970-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- December 3, 2018
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
Reason for Recall
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
Code Information
All lot numbers