Sherlock 9770352YRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741163074), received between Apr 3, 2025 and Aug 28, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Data Problem” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Defective Component; Data Problem; Defective Component; Data Problem

  IT WAS REPORTED THAT A PICC WAS PLACED IN THE RIGHT ARM WITH A 40 CM TRIM FOR TPN ON (B)(6), USING THE 3CG/SHERLOCK FOR CONFIRMATION SINCE THE PATIENT DIDN'T APPEAR TO HAVE A CARDIAC HISTORY THAT COULD INTERFERE WITH CONFIRMATION. IMPLANTING NURSE HAD WHAT SEEMED TO BE A GOOD ECG IMAGE BUT FOUND OUT ON CXR FROM SUBSEQUENT DAYS THAT THE PICC WAS IN FACT DEEP. ON 8/8 THE TEAM CONTACTED US TRYING TO FIND OUT IF THE PICC COULD BE PLAYING A ROLE IN PATIENTS NEW SVT. SINCE WE THOUGHT THIS WAS A LEGITIMATE POSSIBILITY, AND IN AN EFFORT TO REMOVE VARIABLES, A NEW PICC WAS PLACED IN THE LEFT ARM WITH A 44 CM TRIM. RECEIVED AN ECG RHYTHM WITH NEGATIVE DEFLECTION AT -1 (TAPER FULLY INSERTED TO SKIN) AND RETRACTED TO 1 CM OUT WITH THE DEFLECTION DISAPPEARING AND KEEPING LARGE P-WAVE PEAKS AS EXPECTED FOR A WELL POSITIONED LINE. TO FULLY ENSURE POSITION, AN CXR WAS PERFORMED AND THIS NEW LINE WAS ALSO FAR TOO DEEP. THE CONCLUSION WE DREW IS THAT THE PATIENT HAS ABNORMAL BRACHIOCEPHALIC VEIN ANATOMY WHICH WAS THROWING OFF OUR MEASUREMENTS AND CREATING SHORTENED PATHWAYS TO THE SVC. THE CONCERNING PART IS THAT THE 3CG VERIFIED BOTH LINES AS WELL POSITIONED, EVEN THOUGH THE OVER-WIRE EXCHANGE BASE

  Patient problems: Arrhythmia

  MAUDE report 22913757 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT WIRES ARE EXPOSED ON THE CORD. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143454 ↗
• MalfunctionApr 3, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT THE SENSOR IS NO LONGER DETECTING INTERNAL/EXTERNAL WAVE FORM. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767680 ↗