Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Error
PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
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 high-risk medical device where a software/RFID error could lead to incorrect dosing of a cryogen, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
PENTAX of America Inc is recalling four Pentax Medical C2 CryoBalloon Standard 90 degree Catheters, Model FG 1030. The recall is due to a potential defect where incorrect default doses and dose increments may be transmitted to the controller if the catheter's RFID tag is not correct or is not being correctly or completely readable by the controller.
The affected devices are sterile, prescription-only cryosurgical tools intended for endoscopic application and the ablation of dysplastic Barrett's Esophagus. The system includes a CryoBalloon Catheter, Controller, Foot Pedal, and Cartridge containing 36 grams of nitrous oxide. The specific lot/serial number affected is 08062018-03.
Distribution of the recalled devices was made to 17 U.S. states and the District of Columbia, as well as to Canada, Germany, and the Netherlands. There was no government or military distribution. Users should contact PENTAX of America Inc for instructions on how to return the devices.
The recalled product
- Product
- Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: 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…
- Manufacturer
- PENTAX of America Inc
- Affected units
- 4
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)
- Lot/Serial number 08062018-03
Distribution
Part of a larger recall action
This product is one of 3 recalled by PENTAX of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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