Balloon Applicator Kit 720342Recalls & reported problems
Icad, Inc. · Balloon Applicator, 3-4 cm Spherical · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858012005311), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED A CASE OF POTENTIAL SEVERE TOXICITY. THE PATIENT WAS FOUND DECEASED SHORTLY AFTER SURGERY/IRRADIATION. IT IS ASSUMED THAT THE CAUSE MAY HAVE BEEN A PULMONARY EMBOLISM RATHER THAN A CEREBRAL EVENT; HOWEVER, THIS ULTIMATELY REMAINS UNCLEAR, AS AN AUTOPSY WAS DECLINED BY THE FAMILY.
Patient problems: Insufficient Information
MAUDE report 24740286 ↗
Other System, Therapeutic, X-Ray devices
- Xstrahl Photoelectric Therapy SystemXstrahl Limited · System, Therapeutic, X-Ray1 recall0 reports
- INTRABEAM® Spherical Applicator 1.5 cm 304534-6000-557Carl Zeiss Meditec AG · System, Therapeutic, X-Ray1 recall0 reports
- X80 / RADiant / PhotoElectric Therapy System RADiant AuraXstrahl Limited · System, Therapeutic, X-Ray1 report
- INTRABEAM® Needle Applicator 304534-3001-200Carl Zeiss Meditec AG · System, Therapeutic, X-Ray1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.