Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect
Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.
What this means for you
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 risk of harm (partial ejection of the catheter) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter, reference FG-1009. The affected units are identified by lot codes 02132018-01 and 02162018-03. These devices were distributed nationwide in the United States.
The recall is due to a manufacturing defect where the alignment arrow printed on the strain relief is not aligned with the detachment feature of the catheter connector. This misalignment creates a potential for the catheter to be attached to the controller in the detach orientation. In this specific orientation, the catheter is not securely attached to the controller and may be partially ejected from the controller by approximately 1 cm.
The C2 CryoBalloon Ablation System is used as a cryosurgical tool in general surgery, specifically for endoscopic applications. The source text does not report any illnesses, injuries, or deaths associated with this defect. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
- Manufacturer
- PENTAX of America Inc
- Affected units
- 57
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 Codes: 02132018-01 & 02162018-03
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · PENTAX of America Inc
See all →- HighEndoscopy video processors recalled over hot light guide and thermal injury risk
FDA (Devices) · 2025-08-27
- HighPENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall
FDA (Devices) · 2025-03-05
- HighVideo Colonoscope May Cause Thermal Burns to Tissue During Use
FDA (Devices) · 2025-03-05
- HighPentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk
FDA (Devices) · 2025-03-05
- HighPentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions
FDA (Devices) · 2021-09-22
Same hazard · device detachment
See all →- SevereElekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
- SevereMedtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
FDA (Devices) · 2026-07-08
- HighOlympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
FDA (Devices) · 2026-04-29