HeartSpan® 00884450160930Recalls & reported problems
Merit Medical · Class 2
Data updated Oct 16, 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 00884450160930), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT CARDIAC PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE FOR AN ABLATION OF ATRIAL FIBRILATION PROCEDURE, CAUSING CARDIAC TAMPONADE. THE PATIENT UNDERWENT SURGERY TO FACILITATE DRAINAGE AND CARDIAC SUTURE. THE PATIENT WAS THEN ADMITTED TO THE INTENSIVE CARE UNIT FOR RECOVERY. THE PHYSICIAN MADE NO NOTICE OF ANY PROBLEMS WITH THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT.
Patient problems: Cardiac Tamponade
MAUDE report 9469365 ↗
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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