CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report
C2 CryoBalloon Controller recalled by PENTAX of America
Pentax of America is recalling C2 CryoBalloon Controller, distributed nationwide in the US. The recall was initiated on 3 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0970-2019
- FDA event ID
- 81695
- Recalling firm
- Pentax of America, Redwood City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2018
- FDA classified
- 1 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 3 Dec 2018 | Recall initiated by company | |
| 1 Mar 2019 | Classified by FDA | +88 days |
| 13 Mar 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 Esophagus.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
Nationwide CaliforniaDistrict of ColumbiaFloridaLouisianaMassachusettsMarylandMinnesotaNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWashington
Questions about this recall
Why was it recalled?
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Which lots are affected?
All lot numbers
Where was it sold?
Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pentax of America
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Video Processor recalled by Pentax of America | Pentax of America | Other | 20 states |
| Device | CLASS II | Pentax Medical Video Colonoscope- Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Upper GI Scope-Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Processor- Intended to be used recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Colonoscope Family # 1-Pentax Video Colonoscopes recalled | Pentax of America | Other | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |