PENTAX of America Inc: Medical Device Recall in 2019 - (Recall #: Z-0970-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 3, 2018

Date Posted: March 13, 2019

Recall Number: Z-0970-2019

Event ID: 81695

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.

Status: Terminated

Product Quantity: 45

Code Information:

All lot numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated