SherlockRecalls & reported problems across all models
Bard Access Systems, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 305
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 9 models of Sherlock by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 305 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2016 and Mar 23, 2026 — classified as 12 injuries, 293 malfunctions.
The most frequently reported specific device problem is “Data Problem” (137 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Sherlock problems
Device problems
- Data Problem137
- Break52
- No Apparent Adverse Event33
- Malposition of Device23
- Defective Component21
- Device Sensing Problem12
- Application Program Freezes or Fails to Launch6
- Device Operates Differently Than Expected6
Patient problems
- No Clinical Signs, Symptoms or Conditions194
- No Consequences Or Impact To Patient59
- No Known Impact Or Consequence To Patient53
- Discomfort3
- No Information3
- Arrhythmia1
- Atrial Fibrillation1
- Burning Sensation1
Sherlock models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sherlock 9770131Catheter,intravascular,therapeutic,long-term greater than 30 days127 reports
- Sherlock 9770352Catheter, intravascular, therapeutic, long-term greater than 30 days102 reports
- Sherlock 9770131RCatheter,intravascular,therapeutic,long-term greater than 30 days59 reports
- Sherlock 9770353Catheter, intravascular, therapeutic, long-term greater than 30 days5 reports
- Sherlock 9770130Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Sherlock 9770352YCatheter, intravascular, therapeutic, long-term greater than 30 days3 reports
- Sherlock 9770352RCatheter, intravascular, therapeutic, long-term greater than 30 days3 reports
- Sherlock 9770003Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Sherlock 9770132Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
Recent Sherlock adverse event reports
The 15 most recent reports across all models, 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 ↗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 NOT READING IMAGES ACCURATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162123 ↗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 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 ↗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 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 ↗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 ↗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 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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