Sherlock 3CG+ 9770351Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741163029), received between Apr 9, 2021 and Sep 2, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Data Problem” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569738 ↗
• MalfunctionMay 27, 2026Data Problem

  IT WAS REPORTED TABLE IS GIVING INACCURATE P WAVE READINGS. TRIED MULTIPLE SENSORS, ISSUE FOLLOWS TABLE. NO PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299791 ↗
• MalfunctionMay 13, 2026Data Problem

  IT WAS REPORTED LOOSE USB PORT CAUSING THE SENSOR TO GIVE INACCURATE READINGS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160296 ↗
• MalfunctionFeb 26, 2026Product Quality Problem

  IT WAS REPORTED THE TABLET WAS DROPPED. 25 FEB 2026 EVALUATION FOUND ELECTRONIC COMPONENTS WERE EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462499 ↗
• MalfunctionDec 10, 2025No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem

  IT WAS REPORTED THE VASCULAR ACCESS TEAM HAVE HAD INTERMITTENT OCCURRENCES OF CONFIRMING PICCS USING ECG, & FINDING THE CATHETERS PLACED TOO DEEP ON SUBSEQUENT X-RAYS. IT IS POSSIBLE THIS ISSUE IS WITH THE SHERLOCK EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771988 ↗
• MalfunctionSep 10, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT UNIT IS GIVING INACCURATE READING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015612 ↗
• MalfunctionJul 31, 2025No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem

  IT WAS REPORTED THAT THE SURFACE PRO IS GIVING INACCURATE ECG READINGS. TESTED A COUPLE OF SENSORS, BUT THE ISSUE STAYS WITH THE SURFACE PRO. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676257 ↗
• MalfunctionMay 12, 2025Data Problem; Data Problem

  IT WAS REPORTED, HAVING INTERVASCULAR P-WAVE ISSUES WHEN SAVING IMAGES. PER CUSTOMER, TOP AND BOTTOM OF P-WAVE ARE GETTING CUT OFF IN IMAGE. SW VERSION IS 3.1. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007040 ↗
• MalfunctionFeb 3, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT TABLET IS GIVING INCORRECT READINGS. MULTIPLE SENSORS WERE TESTED. ISSUE FOLLOWS TABLET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289370 ↗
• InjuryMar 28, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT ON TWO SEPARATE OCCASIONS, PATIENTS BEGAN HAVING EPISODES OF VTACH SHORTLY AFTER THE INSERTION OF THE PICC AND CONFIRMATION OF MAXIMUM P WAVE. WHEN AN X-RAY WAS COMPLETED, THE TIP OF THE PICC WAS IN THE ATRIUM AND NEEDED TO BE PULLED BACK 5CM FOR ONE PATIENT AND 3CM FOR ANOTHER. THE CHEST PLATE SENSOR WAS CHANGED OUT IN BETWEEN THESE PATIENTS WHICH AGAIN, THE SAME RESULT. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE FIRST PATIENT WITH THE PICC PULLED BACK 5CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000946 ↗
• InjuryMar 28, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT ON TWO SEPARATE OCCASIONS, PATIENTS BEGAN HAVING EPISODES OF VTACH SHORTLY AFTER THE INSERTION OF THE PICC AND CONFIRMATION OF MAXIMUM P WAVE. WHEN AN X-RAY WAS COMPLETED, THE TIP OF THE PICC WAS IN THE ATRIUM AND NEEDED TO BE PULLED BACK 5CM FOR ONE PATIENT AND 3CM FOR ANOTHER. THE CHEST PLATE SENSOR WAS CHANGED OUT IN BETWEEN THESE PATIENTS WHICH AGAIN, THE SAME RESULT. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE SECOND PATIENT WITH THE PICC PULLED BACK 3CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000944 ↗
• MalfunctionAug 16, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE CUSTOMER HAS A 3CG+ TABLET THAT HAS RANDOMLY SHUT DOWN IN THE MIDDLE OF PROCEDURES, NO BATTERY NOTICE OR ANYTHING. THEY REPORTED THAT IT HAS HAPPENED EVEN WHEN THE TABLET IS PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559008 ↗
• MalfunctionMar 8, 2023Data Problem; Data Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE P-WAVE TECHNOLOGY WAS NOT CONSISTENTLY CAPTURING THEIR PEAKED P-WAVES ACCURATELY, CAUSING THEM TO LEAVE TOO MUCH EXTERNAL LENGTH OR ADVANCING TOO FAR IN WITH CATHETER ON THE SMALL TABLET. SAID TECHNOLOGY WAS INCONSISTENT CONFIRMING PLACEMENT, AS SOMETIMES IT WOULD WORK PROPERLY. BUT DUE TO THEIR LACK OF CONFIDENCE IN THE TECHNOLOGY, THEY STILL ORDERED CXR TO CONFIRM TIP PLACEMENT. IT WAS REPORTED BY BD CLINICAL SPECIALIST ¿I WENT TO THE ACCOUNT TODAY TO OBSERVE THEIR SET UP AND PICC INSERTION ON PEDIATRIC PATIENT USING THE SMALL SHERLOCK 3CG TECHNOLOGY. THE TECHNOLOGY DID IN FACT FAIL TO FUNCTION PROPERLY, DESPITE IT BEING USED CORRECTLY. PICC WAS PLACED BEDSIDE. ON THE INSERTION, AS THE CATHETER WAS THREADED INTO THE SVC, IT BEGAN SHOWING BIPHASIC P-WAVES THAT MINIMIZED IN DEFLECTIONS AS THE PICC CONTINUED TO THREAD TOWARDS THE CAJ. ONCE THE PICC WAS AT THE MEASURED LENGTH, IT REFLECTED MAXIMUM PEAKED P-WAVES WITH NO DEFLECTION. I HAD THE INSERTER PUSH THE CATHETER IN FARTHER TOWARDS THE HUB, AND THE P-WAVES BECAME SMALLER WITH NO DEFLECTIONS. AS WE PULLED BACK ON THE CATHETER BEYOND MEASURED LENGTH, IT BEGAN TO SHOW DEFLECTIONS. IT WAS AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501690 ↗
• MalfunctionMar 3, 2023Data Problem; Data Problem

  IT WAS REPORTED THE SENSOR IS NOT ACCURATELY TRACKING PICC. VERIFIED PICC HAS FLUSHED. VERIFIED TABLET HAS BEEN POWER CYCLED TRIED MULTIPLE PICCS. VERIFIED CALIBRATION. NO OTHER UNIT'S AVAILABLE. VERIFIED THEY'RE USING THE TABLET. EMAILED TM TO SEE IF SHE WOULD BE ABLE TO SWING BY WITH HER DEMO UNIT TO TEST IT WITH THEIR TABLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480895 ↗
• MalfunctionJul 7, 2022No Apparent Adverse Event; Unexpected Shutdown; No Apparent Adverse Event; Unexpected Shutdown

  UNIT GIVING ERROR MESSAGE SPORADICALLY AND SHUTTING DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947139 ↗
• MalfunctionJun 22, 2022No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem

  LOLLIPOP WILL APPEAR WITHOUT UNIT BEING ATTACHED AND WILL NOT ALLOW VOICE COMMANDS WHEN THIS HAPPENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14773824 ↗
• MalfunctionOct 22, 2021Unexpected Shutdown; Unexpected Shutdown

  PER TM - BATTERY IS ONLY CHARGING HALF WAY. UNIT WILL CRASH WHEN UNPLUGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682398 ↗
• MalfunctionSep 2, 2021Unexpected Shutdown; Unexpected Shutdown

  PER BIOMED - POWER ISSUE-NOT HOLDING CHARGE, TURNS OFF IMMEDIATELY AFTER BEING UNPLUGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418191 ↗
• MalfunctionApr 9, 2021Unexpected Shutdown; Unexpected Shutdown

  PER TM - IT IS NOT HOLDING A CHARGE AND IT CONTINUES TO REBOOT ITSELF DURING PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642109 ↗