superDimension SDM3Recalls & reported problems
Covidien LP · Fiducial Marker;3-Band · Class 2 · Implant
- 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 10884521198807), received between Sep 13, 2017 and Sep 13, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE FIDUCIAL WAS LEFT BEHIND IN PATIENT AFTER THE VIDEO-ASSISTED THORACOSCOPIC SURGERY. THE PHYSICIAN WAS NOT AWARE THE FIDUCIAL MARKER WAS AN IMPLANTABLE DEVICE AND TOOK THE PATIENT BACK THE NEXT DAY TO RETRIEVED THE FIDUCIAL. THE EVENT EXTEND PATIENT¿S HOSPITALIZATION. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6861373 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.