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.
This recall has been terminated (originally issued December 3, 2018).
- Company
- Pentax Of America Inc
- Recall Initiated
- December 3, 2018
- Terminated
- August 21, 2020
- Recall Number
- Z-0970-2019
- Quantity
- 45
- Firm Location
- Redwood City, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
All lot numbers
Root Cause
Nonconforming Material/Component
Action Taken
On 10/18/18, the firm, Pentax Medical, started contacting US Affected Customers by telephone to inform them of the pending action and to advise they discontinue use and quarantine affected devices. On 12/03/18, "URGENT MEDICAL DEVICE REMOVAL" letters dated 11/16/18 were mailed via USPS Certified Mail to its customers. Customer response forms and Customer Return Material Shipment Labels were mailed with the removal notices. Customers were informed that affected products should not be used and should be returned to the firm. In addition, customers were asked to ensure that all potential users in their facilities are made aware of the removal notice and the recommended actions. Customers were asked to complete and return the Field Action Response Form via: Fax to PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or Email a pdf copy to customeradvisories@pentaxmedical.com, or mail with the returned affected product to:Pentax of America Inc,,303 Convention Way Suite 1, Redwood City, CA 94063, Attention: 2018-009-R Action. . Customers with additional questions were encouraged to call 650-318-5899 (8:30 AM - 5:00 PM, Monday - Friday, PST).