Recall Z-0970-2019— PENTAX of America Inc

Name: FDA recall Z-0970-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-03

Class II · Terminated

Class II FDA medical device recall by PENTAX of America Inc, initiated 2018-12-03, terminated 2020-08-21. It names one FDA 510(k) clearance: K163684. Product: 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: 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..

Recalling firm: PENTAX of America Inc
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Terminated: 2020-08-21
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163684 — C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.·cleared 2018-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.