Agency classClass IIOur severity:High FDA (Devices)·Z-0970-2019·Announced 2019-03-13

Pentax C2 CryoBalloon Controller Recalled for Overpressure Detection Failure

Pentax of America Inc is recalling 45 C2 CryoBalloon Controllers because the device fails to detect balloon overpressure during specific nitrous oxide applications, posing a risk of patient injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that can lead to serious adverse events like perforation or mucosal laceration. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Pentax of America Inc is recalling 45 units of the C2 CryoBalloon Controller (REF: FG-1017) with Controller Software v1.18.258. The C2 CryoBalloon Ablation System is a cryosurgical tool intended for endoscopic application and the ablation of dysplastic Barrett's Esophagus. The recall covers all lot numbers and includes units distributed nationwide in the United States and in Canada, Germany, and the Netherlands.

The recall is due to a defect where the Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide. This failure can contribute to balloon over-pressurization if the intended vent lumen of the catheter is significantly occluded, such as by a kinked catheter condition. If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.

Healthcare facilities and consumers who have this device should stop using it immediately and contact Pentax of America Inc for further instructions on the recall.

The recalled product

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…
Manufacturer: PENTAX of America Inc
Category: Medical Device — Endoscopic Surgical Instrument
Hazard: overpressure
perforation
laceration
Affected units: 45

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lot numbers

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · PENTAX of America Inc

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Same hazard · overpressure