Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors
Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal 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 functional defect could lead to incorrect dosing during a surgical procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Pentax of America Inc is recalling 157 units of the Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028. The recall was initiated because incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool for endoscopic application and the ablation of dysplastic Barrett's Esophagus. The system includes the CryoBalloon Catheter, Controller, Foot Pedal, and a CryoBalloon Cartridge containing 36 grams of nitrous oxide.
Distribution was made to California, District of Columbia, Florida, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington. Foreign distribution was made to Canada, Germany, and the Netherlands. There was no government or military distribution. Affected lot and serial numbers include 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01. Users should contact Pentax of America Inc for further instructions.
The recalled product
- Product
- Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, 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
- 157
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 (8)
- Lot/Serial numbers: 06152018-02
- 06252018-03
- 07062018-01
- 07232018-02
- 08102018-01
- 08172018-06
- 08292018-04
- and 9172018-01.
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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