NeuroBalloon™ 7CBD10Recalls & reported problems
Integra LifeSciences Switzerland Sàrl · NeuroBalloon™ NEUROBALLOON™ CATHETER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780035343), received between Jan 14, 2022 and Jan 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2022Break; Break
A FACILITY REPORTED THAT THE NEURO BALLOON CATHETER (7CBD10) WAS TESTED BEFORE USE ACCORDING TO THE INSTRUCTIONS, BUT THE BALLOON WAS BROKEN DURING USE. NO PATIENT INJURY OR DEATH ALLEGED AND THE EVENT DID NOT LEAD TO AN INCREASE OF SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13257857 ↗
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- NA 1120Advanced Neuromodulation Systems, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- RELIANCE LITe 48060500Stryker Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
- AESCULAP FV002RAesculap AG · INSTRUMENT, SURGICAL, NON-POWERED1 report
- DBS™ 3755Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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