AVAflex AFB1020Recalls & reported problems
Carefusion 2200, Inc · AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX20MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403223242), received between Jul 11, 2018 and Jul 11, 2018 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2018Break; Detachment of Device or Device Component; Physical Resistance/Sticking
PT WAS HAVING A KYPHOPLASTY PROCEDURE LEVEL T-12 WAS BEING DONE WHEN THE NEEDLE GOT STUCK AND BROKE OFF. THE DR WAS ABLE TO GET THE NEEDLE OUT AFTER MAKING A LARGER INCISION. MADE A LARGER INCISION AND WAS ABLE TO RETRIEVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 7681162 ↗
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- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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