Skip to content

AVAflex AFB1015Recalls & reported problems

Carefusion 2200, Inc · AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX15MM · Class 2

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 10885403223259), received between Jul 19, 2018 and Jul 19, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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 19, 2018Break; Break

    IT WAS REPORTED THAT THE WHILE REMOVING THE NEEDLE TO INJECT MORE CEMENT, THE CEMENT HARDENED AND THE NEEDLE BROKE OFF IN THE PATIENT. THERE WAS A CLINICALLY SIGNIFICANT MEDICAL DELAY AS THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE DEVICE MATERIAL LEFT BEHIND. A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 7702434 ↗

Other Cement, Bone, Vertebroplasty devices

All Cement, Bone, Vertebroplasty devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.