JADA System 1047196Recalls & reported problems
GI Supply, Inc. · Vacuum-induced Hemorrhage Control System · 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 00893029002762), received between Aug 29, 2026 and Aug 29, 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
- Insufficient Device Problem Information1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 29, 2026Insufficient Device Problem Information
Vaginal delivery with post-partum hemorrhage requiring JADA intervention. There was bleeding around JADA which prompted removal, at which time cervical laceration was noted. Laceration was repaired and transfusion protocols were implemented. Patient was transferred to the ICU where an additional transfusion protocol was initiated post-hysterectomy. Patient died during admission. No additional details known/reported.
Patient problems: Laceration(s)
MAUDE report 50510205 ↗
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
- Ebb® Complete Tamponade System CTS-1000Clinical Innovations, LLC · Intrauterine Tamponade Balloon1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.