Intrauterine Tamponade Balloon
FDA adverse event reports and recall history for intrauterine tamponade balloon (product code OQY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,322
- Deaths
- 8
- Injuries
- 658
- Malfunctions
- 654
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-10-15TerminatedOther
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
- 2015-01-27TerminatedProcess design
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Monitor intrauterine tamponade balloon automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.