superDimension SDM2Recalls & reported problems
Covidien LP · Fiducial Marker;2-Band · Class 2 · Implant
All models of superDimension (20)
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 10884521198791), received between Aug 14, 2017 and Aug 14, 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. 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
- Blood Loss1
- Hemostasis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD AN ENB PROCEDURE ON (B)(6) 2011. NINE DAYS FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL WITH HEMOPTYSIS AND A MAJOR HEMOSTASIS FROM A BLOOD CLOT ON THE RIGHT SIDE NEAR THE LOCATION OF THE TARGET LESION. THE PATIENT WAS HOSPITALIZED AND REQUIRED VENTILATOR SUPPORT. EMBOLIZATION WAS PERFORMED ON (B)(6) 2011. THE DOCTOR DID NOT ALLEGE ANY SYSTEM DEFICIENCY, HOWEVER NEW INFORMATION RECEIVED ATTRIBUTED THE HEMOPTYSIS TO THE PLACEMENT OF THE FIDUCIAL MARKER. THE PATIENT RECOVERED AND WAS SUBSEQUENTLY DISCHARGED 1-2 DAYS AFTER THE EMBOLIZATION.
Patient problems: Blood Loss; Hemostasis
MAUDE report 6791198 ↗
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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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