Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors
Pentax of America Inc is recalling 68 C2 CryoBalloon Pear 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Pentax of America Inc is recalling 68 units of the Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024. The recall is due to a 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 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 Cartridge containing nitrous oxide. The affected lot and serial numbers are 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.
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. Healthcare providers should stop using the affected devices and contact Pentax of America Inc for instructions on return or replacement.
The recalled product
- Product
- Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, 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
- 68
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 (5)
- Lot/Serial numbers: 06152018-01
- 07172018-02
- 07022018-04
- 08212018-01
- and 08102018-03.
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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