Ebb® Complete Tamponade System CTS-1000Recalls & reported problems
Clinical Innovations, LLC · Ebb® Complete Tamponade System · Class 2
Data updated Oct 18, 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 00814247020765), received between Apr 9, 2020 and Apr 9, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Miscarriage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2020Use of Device Problem; Use of Device Problem
THE EBB WAS USED ON A PATIENT AFTER A MISCARRIAGE IN THE FIRST TRIMESTER OF PREGNANCY. THE PHYSICIAN USED THE EBB IN ORDER TO STOP THE PATIENT'S BLEEDING AFTER THE MISCARRIAGE AND TO AVOID A HYSTERECTOMY. THE EBB BALLOON BURST AFTER THE PHYSICIAN PRESSED HIS FINGERS AGAINST IT.
Patient problems: Miscarriage
MAUDE report 9946644 ↗
Other Intrauterine Tamponade Balloon devices
- Bakri G30673Cook Incorporated · Intrauterine tamponade balloon355 reports
- Bakri G24237Cook Incorporated · Intrauterine tamponade balloon229 reports
- Jada™ System JADA-1001Alydia Health, Inc. · Intrauterine Tamponade Balloon207 reports
- JADA System JADA-2002Organon LLC · Intrauterine tamponade balloon4 deaths74 reports
- JADA System 1047196GI Supply, Inc. · Intrauterine Tamponade Balloon1 death1 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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