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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPentax Medical Video Processor; Model Number: EPK-i8020c;2025-07-16
- FDAPENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c2025-01-29
- FDAPENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL2025-01-29
- FDAPentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c2025-01-29
- FDAColonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channel...2021-07-14
- FDAGastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels ...2021-07-14
- FDAPentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.2021-04-21
- FDA9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal2020-09-22
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