Atlas Positioner Attachment 45062Recalls & reported problems
Terumo Cardiovascular Systems Corporation
Data updated Oct 18, 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 00699753450622), received between Mar 9, 2020 and Mar 9, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Injury1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2020Use of Device Problem; Use of Device Problem
DURING A PERFORMANCE SURVEY THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THEY STOP USING THE ATLAS POSITIONER BECAUSE IT FREQUENTLY TEARS THE EPICARDIUM MAKING IT DIFFICULT TO FIX THE BLEEDING. NO OTHER INFORMATION ABOUT THE NATURE OF THE EVENT WAS PROVIDED.
Patient problems: Injury; Tissue Damage
MAUDE report 9808680 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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