HeartSpan® 00884450693704Recalls & 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
- 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 00884450693704), received between Feb 4, 2025 and Feb 4, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2025Use of Device Problem; Use of Device Problem
THE ACCOUNT ALLEGES THAT DURING A STRUCTURAL HEART INTERVENTION [LAA] PROCEDURE, VESSEL TRAUMA OCCURRED. THE ACCOUNT BELIEVES THIS WAS DUE TO USE ERROR. THE OPERATOR HAD APPLIED TOO MUCH PRESSURE DURING THE PUNCTURE [TENTING] ULTIMATELY BREAKING THROUGH THE SEPTAL WALL WITH THE ACCESS SHEATH RESULTING IN DAMAGE TO THE ATRIAL ROOF. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Perforation
MAUDE report 21304805 ↗
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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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