Sherlock 9770131RRecalls & reported problems
Bard Access Systems, Inc. · REFURB, SHERLOCK 3CG TCS SENSOR · Class 2
Quick summary
This Bard Sherlock sensor is a catheter-tip position sensor used to confirm that a PICC line is correctly placed inside the vein. The 59 reports mostly describe the sensor giving wrong or unreliable readings about where the line sits, and parts cracking, breaking, or a housing that will not stay closed. None of the reports describe a death or an injury. There are no recalls naming this device, and no reports were filed in the past 12 months compared with 2 in the prior 12 months.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00801741125300), received between Aug 29, 2018 and May 1, 2025 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Data Problem” (25 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 Problem25
- Break13
- Defective Component6
- No Apparent Adverse Event5
- Device Sensing Problem4
- Incorrect, Inadequate or Imprecise Result or Readings3
- Device Displays Incorrect Message2
- Failure to Calibrate2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient25
- No Known Impact Or Consequence To Patient8
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Data Problem; Data Problem
IT WAS REPORTED THAT THE SHERLOCK DEVICE IS NOT WORKING CORRECTLY (NO P WAVE ELEVATION). CUSTOMER HAS NEEDED TO CXR. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941816 ↗MalfunctionNov 7, 2024Break; Break
IT WAS REPORTED THAT THE HOUSING OF THE SHERLOCK WILL NOT STAY CLOSED RESULTING IN THE WIRES BEING EXPOSED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20631654 ↗MalfunctionMay 1, 2024Data Problem; Data Problem
IT WAS REPORTED THAT SENSOR IS GIVING INACCURATE READINGS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226622 ↗MalfunctionApr 4, 2024Data Problem; Data Problem
IT WAS REPORTED THAT THE TRACKING IS ERRATIC AND INACCURATE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19048174 ↗MalfunctionMar 23, 2024Data Problem; Data Problem
IT WAS REPORTED THAT THE SENSOR IS HAVING ISSUES TRACKING PICC ACCURATELY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966249 ↗MalfunctionNov 6, 2023Data Problem; Data Problem
IT WAS REPORTED THE SENSOR INTERMITTENTLY INACCURATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080604 ↗MalfunctionMay 11, 2023Data Problem; Data Problem
IT WAS REPORTED WHEN PLACING A PICC LINE, THE WAVE LINE LOOKS FINE, BUT THE LOLLIPOP IS NOT TURNING GREEN AND OFTEN GIVES INACCURATE LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16916899 ↗MalfunctionFeb 22, 2023Data Problem; Data Problem
IT WAS REPORTED THE USER IS HAVING ACCURACY ISSUES WITH THE SENSOR; STATING THAT IT WILL SHOW THE PICC IS IN PLACE BUT IT'S OFF CONSIDERABLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16425162 ↗MalfunctionDec 2, 2022Failure to Calibrate; Data Problem; Failure to Calibrate; Data Problem
SENSOR NOT PICKING UP THE 3CG RHYTHM AND THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15902298 ↗MalfunctionJun 22, 2022Data Problem; Data Problem
NOT ACCURATELY TRACKING THE PICC LINE AS THE UNIT IS SHOWING THAT THE LINE IS COILING WHEN IT'S NOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776197 ↗MalfunctionJun 15, 2022Break; Break
PER BIOMED: CORD IS PULLING AWAY AT THE STRAIN RELIEF EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14706142 ↗MalfunctionJun 15, 2022Break; Break
PER BIOMED: CORD HAS PULLED AWAY AT THE STRAIN RELIEF, EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14705526 ↗MalfunctionJun 4, 2022Defective Component; Data Problem; Defective Component; Data Problem
PER PICC RN - THIS UNIT IS NO LONGER ACCURATE FROM A MAGNET TRACKING OR ECG STAND POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599219 ↗MalfunctionFeb 11, 2022Break; Break
PER BIOMED - THE WIRES ARE SHOWING AND A PIECE OF THE CASING IS BROKEN AND CRACKED IN MULTIPLE AREAS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13514878 ↗MalfunctionJan 12, 2022Data Problem; Data Problem
PER BIOMED - WHILE PLACING A PICC THE YELLOW LINE WENT WAY ABOVE WHERE IT SHOULD HAVE BEEN. PLACEMENT WAS VERY OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13239619 ↗MalfunctionDec 16, 2021Break; Defective Component; Break; Defective Component
SHERLOCK SENSOR HAS A BROKEN HOUSING AND HAS WIRES EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13018488 ↗MalfunctionNov 7, 2021Data Problem; Data Problem
PER TM, THE SHERLOCK IS SHOWING THAT THE PICC IS IN THE RIGHT PLACE AND THEN WHEN THEY GET A CHEST X-RAY, THE X-RAY IS SHOWING THAT THE PICC IS MUCH TOO DEEP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12760725 ↗MalfunctionOct 7, 2021No Apparent Adverse Event; No Apparent Adverse Event
PER BIOMED, THE TOP OF THE PICC CONTINUES TO GO STRAIGHT; X-RAYS NEEDED FOR CONFIRMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12590912 ↗MalfunctionJul 8, 2021Break; Break
PER BIOMED - CORD IS PULLING AWAY, EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12137358 ↗MalfunctionJul 8, 2021Data Problem; Data Problem
PER BIOMED - TIP CONFIRMATION APPEARS TO BE OFF CALIBRATION, GIVING INCORRECT READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12136383 ↗MalfunctionJun 9, 2021Break; Defective Component; Break; Defective Component
PER BIOMED - SENSOR HAS EXPOSED WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11966720 ↗MalfunctionJun 8, 2021Break; Break
PER BIOMED - STRAIN RELIEF IS PULLING AWAY AND EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11962966 ↗MalfunctionJun 2, 2021No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
PER TM - THE TIP ON THE SENSOR IS NOT TRACKING, GIVING INCORRECT READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11922808 ↗MalfunctionMay 13, 2021Data Problem; Data Problem
PER BIOMED - TRACKING FOR PICC PLACEMENT IS OFF, ALSO NOT GIVING THE P WAVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11821896 ↗MalfunctionApr 9, 2021Break; Break
PER BIOMED - WIRES EXPOSED BY STRAIN RELIEF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641993 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.