Sherlock 9770352Recalls & reported problems
Bard Access Systems, Inc. · Sherlock 3CG Sensor · Class 2
Quick summary
This Bard Sherlock 3CG sensor is a tip-location sensor used when placing long-term catheters such as PICCs. Its 102 FDA reports mostly describe inaccurate readings and data problems, with some reports of parts breaking, the app freezing, and unexpected shutdowns. The reports include no deaths and no injuries. 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
- 102
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00801741163043), received between Nov 12, 2020 and Feb 11, 2026 — classified as 102 malfunctions.
The most frequently reported specific device problem is “Data Problem” (60 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 Problem60
- Break25
- No Apparent Adverse Event23
- Defective Component8
- Application Program Freezes or Fails to Launch3
- Material Protrusion/Extrusion2
- Unexpected Shutdown2
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Data Problem
IT WAS REPORTED THE SENSOR GIVING INACCURATE READINGS, SHUT DOWN DURING USE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316503 ↗MalfunctionFeb 4, 2026Data Problem
IT WAS REPORTED BY A TM- ITS LAGGING AND NOT PICKING UP FOR TIP LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258171 ↗MalfunctionFeb 3, 2026Product Quality Problem; Data Problem
IT WAS REPORTED, WAVEFORM NOT READING CORRECTLY WHEN PLACING PICC. DOESN'T HAVE OTHER SENSORS. HAVE TRIED MULTIPLE ULTRASOUNDS AND HAVING THE SAME ISSUE ON EACH. BIOMED NOT ABLE TO TEST UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251492 ↗MalfunctionFeb 2, 2026Data Problem
CUSTOMER REPORTED SHORT PICCS. NO OTHER INFORMATION WAS PROVIDED. AN EXACT QUANTITY OF SHORT PICCS WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235050 ↗MalfunctionJan 23, 2026Data Problem
IT WAS REPORTED SENSOR IS GIVING INACCURATE READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162125 ↗MalfunctionJan 23, 2026Data Problem
IT WAS REPORTED THE SENSOR IS GIVING INACCURATE READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162114 ↗MalfunctionDec 22, 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 23864853 ↗MalfunctionDec 10, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SR8 REPORTED GOOD POSITIONING BUT THE PICC WAS TOO DEEP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771982 ↗MalfunctionNov 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
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 23606349 ↗MalfunctionNov 4, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS GIVING ERROR MESSAGES, INACCURATE READINGS AND IS MISSING THE LOLLIPOP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468318 ↗MalfunctionAug 27, 2025Break; Break
OBSERVATION FOUND DURING EVALUATION AT BD SERVICE CENTER: THAT CONDUCTIVE WIRING WAS EXPOSED FROM THE END OF THE USB CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905079 ↗MalfunctionAug 21, 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 22865639 ↗MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THE CORD HAS FRAYED, WIRING EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22728733 ↗MalfunctionJul 31, 2025Data Problem; Data Problem
IT WAS REPORTED NEW SENSOR IS PRODUCING INCONSISTENT P-WAVES AND IS GIVING NEGATIVE P-WAVES, EVEN AFTER PULLING BACK THE PICC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676266 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED THAT THE STRAIN RELIEF CORD WIRES ARE EXPOSED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301965 ↗MalfunctionJun 19, 2025Data Problem; Data Problem
IT WAS REPORTED THE SENSOR IS GIVING INACCURATE READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289951 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER CORD PULLED AWAY FROM STRAIN RELIEF AND IS EXPOSING WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22179598 ↗MalfunctionMay 1, 2025Break; Data Problem; Break; Data Problem
IT WAS REPORTED BY A TM THAT THE UNIT IS INTERMITTENTLY GIVING INCORRECT PICC PLACEMENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941832 ↗MalfunctionApr 30, 2025Data Problem; Data Problem
IT WAS REPORTED BY A TM THAT THE UNIT IS INTERMITTENTLY GIVING INCORRECT PICC PLACEMENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939745 ↗MalfunctionMar 28, 2025Data Problem; Data Problem
IT WAS REPORTED OF HAVING ISSUES WITH THE SENSOR INACCURATELY DETECTING PICC. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21719509 ↗MalfunctionMar 18, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS HAVING INACCURATE P-WAVE AND PICC DETECTION ISSUES. SEEMS TO BE HAPPENING ON EVERY PATIENT. CUSTOMER HAS TO GET CXR TO CONFIRM AND ENDS UP BEING EXTREMELY INACCURATE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635627 ↗MalfunctionMar 13, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS HAVING ISSUES DISPLAYING THE CARDIAC RHYTHM CONSISTENTLY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21601812 ↗MalfunctionFeb 26, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE SENSOR LOSSES CONNECTION MID PROCEDURE. DIFFERENT SENSORS WERE TRIED FOR MULTIPLE ULTRASOUNDS. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471073 ↗MalfunctionNov 19, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED; SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726031 ↗MalfunctionAug 14, 2024Data Problem; Data Problem
IT WAS REPORTED DEVICE GIVING INACCURATE READINGS; NO OK SIGNAL THAT THE PICC LINE IS IN THE RIGHT PLACE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19988634 ↗
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.