superDimension SDAN2000 (UDI 10884521843202)Recalls & reported problems
Covidien LP · Pre-marked Aspirating Needle · Class 1
All models of superDimension (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521843202), received between Apr 1, 2024 and Apr 4, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Application Network 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
- Application Network Problem1
- Improper or Incorrect Procedure or Method1
- Positioning Failure1
Patient problems
- Pneumothorax2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2024Positioning Failure; Application Network Problem; Positioning Failure; Application Network Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO NEEDLES HAD DIFFICULTY DEPLOYING, AND DID NOT GET ANY TISSUE SAMPLE. IT WAS NOTED THAT THE NODULE CHARACTERISTICS (HARD TISSUE) OR WERE NOT IN THE CORRECT SPOT FOR DEPLOYMENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. HOWEVER, AFTER THE PROCEDURE, THE PATIENT HAD PNEUMOTHORAX WHICH RESULTED IN EXTENDED HOSPITALIZATION. TO RESOLVE THE ISSUE, A CHEST TUBE WAS USED.
Patient problems: Pneumothorax
MAUDE report 19047949 ↗InjuryApr 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO NEEDLES HAD DIFFICULTY DEPLOYING, AND DID NOT GET ANY TISSUE SAMPLE. IT WAS NOTED THAT THE NODULE CHARACTERISTICS (HARD TISSUE) OR WERE NOT IN THE CORRECT SPOT FOR DEPLOYMENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. HOWEVER, AFTER THE PROCEDURE, THE PATIENT HAD PNEUMOTHORAX. REPORT 2 OF 2.
Patient problems: Pneumothorax
MAUDE report 19011047 ↗
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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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