Emprint SX CABK8816Recalls & reported problems
Covidien LP · Open Ultrasound Tracking Sensor. For use with BK Medical. Type 8816 open ultrasound probes · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521703339), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, IT WAS NOTICED THAT THE TIP WAS BROKEN, NOT OFF, WHEN SENSOR WAS REMOVED FROM THE PATIENT. AS SENSOR WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE TIP THAT SECURED THE SENSOR TIP TO THE ULTRASOUND PROBE WAS BENT. THE TECH TOOK BOTH ITEMS, REMOVED THE SENSOR FROM THE ULTRASOUND PROBE AND BENT THE TIP OFF, BREAKING IT OFF. THE SENSOR PROBE WAS PLACED ON THE ULTRASOUND UNIT THAT ALREADY HAD A PLASTIC SHEATH OVER IT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH INCIDENT DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695001 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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