Sherlock 9770131Recalls & reported problems
Bard Access Systems, Inc. · SHERLOCK 3CG TCS SENSOR · Class 2
Quick summary
This Bard Sherlock sensor is a tool used to guide placement of a long-term IV catheter using heart signals. Of its 127 reports, 116 are malfunctions and 11 are injuries, with no deaths; many describe inaccurate or unclear readings, and some describe cords or wires broken or exposed. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00801741124341), received between Aug 18, 2016 and Mar 23, 2026 — classified as 11 injuries, 116 malfunctions.
The most frequently reported specific device problem is “Data Problem” (43 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Data Problem43
- Malposition of Device21
- Break11
- Device Sensing Problem8
- Defective Component5
- Device Operates Differently Than Expected5
- Material Integrity Problem4
- Positioning Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Known Impact Or Consequence To Patient44
- No Consequences Or Impact To Patient27
- Discomfort3
- No Information3
- Atrial Fibrillation1
- Burning Sensation1
- Complaint, Ill-Defined1
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Data Problem
IT WAS REPORTED CUSTOMER HAVING ISSUES GETTING SENSOR TO ACCURATELY DETECT PWAVE. VERIFIED THEY ARE FLUSHING PICC PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668452 ↗MalfunctionJan 23, 2026Data Problem
IT WAS REPORTED THE SENSOR IS NOT READING IMAGES ACCURATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162123 ↗MalfunctionDec 16, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE EKG WHITE LINE IS FINE BUT YELLOW LINE IS NOT GIVING A P-WAVE, JUMP TO BE IN THE MIDDLE OF THE SENSOR PICTURE ON SCREEN. COULD NOT GET TO TURN GREEN. HAVE TESTED OTHER SENSORS AND THIS IS THE ONLY ONE THAT IS GIVING THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818638 ↗MalfunctionNov 11, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526478 ↗MalfunctionOct 29, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418799 ↗MalfunctionJul 1, 2025Break; Defective Component; Break; Defective Component
IT WAS REPORTED ULTRASOUND TRANDUCER CORD BROKEN AND WIRE EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378350 ↗MalfunctionAug 28, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED THE SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20088936 ↗MalfunctionJul 17, 2024Break; Break
IT WAS REPORTED THAT THE SHERLOCK WAS DROPPED AND WIRES ARE EXPOSED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19762086 ↗MalfunctionJun 26, 2024Data Problem; Data Problem
IT WAS REPORTED THE SENSOR IS GIVING INCORRECT READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19614726 ↗MalfunctionMay 21, 2024Data Problem; Data Problem
IT WAS REPORTED THE SENSOR IS GIVING INCORRECT READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19361155 ↗MalfunctionMay 16, 2024Break; Break
IT WAS REPORTED THAT THE HOUSING IS BROKEN (COME AWAY FROM SCREWS SO DOESN¿T SECURE) AND WIRES EXPOSED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19334417 ↗MalfunctionMay 2, 2024Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19235777 ↗MalfunctionApr 11, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED BY THE VASCULAR ACCESS TEAM THAT THE LOLLIPOP HASN'T BEEN STAYING CONSISTENT. LAST NIGHT IT DID THOUGH. NEW INFO RECEIVED 03/21/2024: WE HAD ANOTHER INSTANCE WHERE WE GOT THE DIAMOND, BUT CXR TWO DAYS LATER SAID IT WAS 3 CM TOO DEEP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088584 ↗MalfunctionFeb 20, 2024Data Problem; Data Problem
SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738875 ↗MalfunctionJan 12, 2024Break; Break
IT WAS REPORTED THE SENSOR IS NO LONGER BEING RECOGNIZED - CORD HAS PULLED AWAY, EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18504496 ↗MalfunctionJan 4, 2024Data Problem; Data Problem
IT WAS REPORTED THE UNIT IS GIVING INACCURATE READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445047 ↗MalfunctionOct 4, 2023Data Problem; Data Problem
IT WAS REPORTED THE SENSOR WAS STATING TO HAVE DEPTH ISSUES AS IT WAS SAYING THE PICC WAS 5-6CM OFF ITS TARGET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873153 ↗MalfunctionSep 19, 2023Data Problem; Data Problem
IT WAS REPORTED BY VAT: SOMETIMES SHOWS NO IMAGE OF PICC BEING PASSED EVEN WHEN IT IS BEING PASSED. AT TIMES SHOWS PICC COMING FROM THE LEFT WHEN BEING PASSED FROM THE RIGHT. AT TIMES SHOWS PICC GOING UP THE NECK WHEN IT IS ACTUALLY GOING DOWN. THE ECG READING/OR PICC SHOWING UP ON SCREEN WHEN NO PICC IS BEING PASSED INTO PATIENT. SHERLOCK ALSO GETS STUCK WHEN CALIBRATING AND HAVE HAD TO SHUT DOWN ENTIRE SYSTEM TO GET IT TO RUN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773575 ↗MalfunctionSep 19, 2023Data Problem; Data Problem
IT WAS REPORTED THE CUSTOMER IS HAVING INTERMITTENT ISSUES WITH SENSOR BEING INACCURATE WHEN PLACING PICC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773401 ↗MalfunctionAug 31, 2023Data Problem; Data Problem
IT WAS REPORTED THE SENSOR IS GIVING ERRATIC AND INCORRECT READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17658880 ↗MalfunctionJul 5, 2023Break; Break
IT WAS REPORTED THE CORD HAS BEEN PULLED FROM THE SENSOR/EXPOSING WIRES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17259405 ↗MalfunctionJun 6, 2023Break; Break
FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE SENSORS HOUSINGS ARE CHIPPED AND CRACKED. THE USB CABLE IS PULLING OUT OF THE SENSOR HOUSING, EXPOSING WIRES. THESE ISSUES ARE DUE TO USE OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070988 ↗MalfunctionMar 3, 2023Data Problem; Data Problem
IT WAS REPORTED THE ECG READINGS ARE NOT CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16480907 ↗MalfunctionJan 28, 2023Break; Break
IT WAS FOUND DURING EVALUATION AT A SERVICE FACILITY: THE SENSORS BOTTOM HOUSING IS BROKEN AT TWO SCREW HOLES, CAUSING THE HOUSINGS TO SEPARATE. THE USB CABLE IS PULLING OUT OF THE SENSOR HOUSING, CAUSING WIRES TO BE EXPOSED. THE USB CABLE IS DISCOLORED. THESE ISSUES ARE DUE TO USE OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261247 ↗MalfunctionDec 30, 2022Data Problem; Data Problem
IT WAS REPORTED BY THE CUSTOMER "PLACEMENT IS NOT ACCURATE. WE ARE GETTING A WAVE FORM, BUT THE PLACEMENT WILL BE OFF." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16080561 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.