HeartSpan® 00884450630754Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of HeartSpan (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450630754), received between Aug 8, 2024 and Aug 8, 2024 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT POST TRANSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION [PVI] PROCEDURE, A TRANSESOPHAGEAL ECHO [TEE] WAS ORDERED TO DETERMINE THE CAUSE OF BLOOD PRESSURE CHANGES IN THE PATIENT. THE TEE ACCURATELY IDENTIFIED 13MM PERICARDIAL EFFUSION/FLUID COLLECTING WITHIN THE PATIENT'S PERICARDIAL SAC. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO PREVENT CARDIAC TAMPONADE FOR THIS PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19944178 ↗InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT POST TRANSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION [PVI] PROCEDURE, A TRANSESOPHAGEAL ECHO [TEE] WAS ORDERED TO DETERMINE THE CAUSE OF BLOOD PRESSURE CHANGES IN THE PATIENT. THE TEE ACCURATELY IDENTIFIED PERICARDIAL EFFUSION/FLUID COLLECTING WITHIN THE PATIENT'S PERICARDIAL SAC. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO PREVENT CARDIAC TAMPONADE FOR THIS PATIENT. THE BLEEDING COULD NOT BE STOPPED IN THE FURTHER COURSE OF THE PROCEDURE. SURGERY WAS REQUIRED. NO ADDITIONAL PATIENT COMPLICATIONS TO REPORT. THE DEVICE WAS DISCARDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19943337 ↗
Other Trocar devices
- BRK™ G407208St. Jude Medical Cardiovascular Division · Trocar3 deaths75 reports
- BRK™ 407200St. Jude Medical Cardiovascular Division · Trocar4 deaths71 reports
- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- Cook G02365Cook Incorporated · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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