Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 13, 2019
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pentax of America Inc recalled C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 Cry… - a moderate-severity action.
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 Cry… was recalled by Pentax of America Inc in March 13, 2019. Reason: The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitr…. Check the official notice for the remedy. Verify recall #Z-0970-2019 with the FDA Devices before acting.
The recall
Pentax of America Inc issued this moderate-severity FDA Devices recall-The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitr….
- Moderate
- severity level
- 45 units
- affected scope
- Class II
- classification
- March 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0970-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0970-2019) was formally reported on March 13, 2019, with the manufacturer initiating the action on December 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Pentax of America Inc is listed as the recalling firm, operating out of Redwood City, CA. Federal records list the affected scope as 45.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0970-2019 |
| Date reported | March 13, 2019 |
| Date initiated | December 3, 2018 |
| Recalling firm | Pentax of America Inc |
| Firm location | Redwood City, CA |
| Affected scope | 45 |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0970-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pentax of America Inc. Units affected: 45.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Moderate. Recall number: Z-0970-2019.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0970-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.