MONOPTYRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 13 models of MONOPTY by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Oct 28, 2025 — classified as 7 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Self-Activation or Keying” (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. 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 MONOPTY problems
Device problems
- Self-Activation or Keying60
- Difficult to Remove17
- Failure to Prime14
- Failure to Obtain Sample13
- Failure to Fire12
- Device Contamination with Chemical or Other Material10
- Adverse Event Without Identified Device or Use Problem6
- Unsealed Device Packaging5
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Consequences Or Impact To Patient22
- No Patient Involvement15
- Hematuria3
- Hemorrhage/Blood Loss/Bleeding2
- No Known Impact Or Consequence To Patient1
- Pain1
- Pneumothorax1
MONOPTY models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MONOPTY 121410INSTRUMENT, BIOPSY30 reports
- MONOPTY 121610INSTRUMENT, BIOPSY12 reports
- MONOPTY 121616INSTRUMENT, BIOPSY12 reports
- MONOPTY 121816INSTRUMENT, BIOPSY10 reports
- MONOPTY 211610INSTRUMENT, BIOPSY10 reports
- MONOPTY 121820INSTRUMENT, BIOPSY7 reports
- MONOPTY 211616INSTRUMENT, BIOPSY6 reports
- MONOPTY 121620INSTRUMENT, BIOPSY4 reports
- MONOPTY 211816INSTRUMENT, BIOPSY4 reports
- MONOPTY 122016INSTRUMENT, BIOPSY2 reports
- MONOPTY 121210INSTRUMENT, BIOPSY1 report
- MONOPTY 121416INSTRUMENT, BIOPSY1 report
- MONOPTY 121810INSTRUMENT, BIOPSY1 report
Recent MONOPTY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Break; Self-Activation or Keying; Device Dislodged or Dislocated; Break; Self-Activation or Keying; Device Dislodged or Dislocated
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MONOPTY DEVICE, UPON OPENING THE NEEDLE BOX, THE INSTRUMENT BODY WAS BROKEN. ANOTHER CANNULA NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399703 ↗InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ECHO-GUIDED LIVER BIOPSY PROCEDURE, THE INNER CYLINDER HAD ALLEGEDLY TORE THE PATIENT'S GALLBLADDER WALL. IT WAS FURTHER REPORTED THAT THE PATIENT HAD ALLEGEDLY DEVELOPED CHOLECYSTITIS AFTER THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Rupture
MAUDE report 21444596 ↗MalfunctionAug 13, 2024Self-Activation or Keying; Failure to Fire; Material Twisted/Bent; Self-Activation or Keying; Failure to Fire; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ECHO GUIDED BREAST BIOPSY PROCEDURE, THE OUTER TUBE ALLEGEDLY DID NOT FIRE, AND THE SAMPLE CANNOT BE COLLECTED PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970030 ↗MalfunctionJul 22, 2024Self-Activation or Keying; Failure to Obtain Sample; Self-Activation or Keying; Failure to Obtain Sample
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19792438 ↗MalfunctionJun 4, 2024Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample; Failure to Prime; Self-Activation or Keying; Failure to Obtain Sample
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE TISSUE ALLEGEDLY COULD NOT BE REMOVED. A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19456546 ↗MalfunctionMay 25, 2024Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS DESIGNED TO BE EJECTED AFTER TWO ROTATIONS FOR THE SET, BUT THE NEEDLE WAS ALLEGEDLY EJECTED ON ITS OWN ON THE SECOND ROTATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19398161 ↗MalfunctionApr 13, 2024Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, WHEN THE GREEN GRIP WAS TURNED TWICE FOR SETTING, THE OUTER CYLINDER OF THE DEVICE ALLEGEDLY FIRED ON ITS OWN. A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102705 ↗MalfunctionApr 3, 2024Failure to Prime; Self-Activation or Keying; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Fire
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE PRIMED AND IT SUDDENLY FIRED. IT WAS FURTHER REPORTED THAT, AFTER THE DEVICE WAS PRIMED SUCCESSFULLY, BUT THE DEVICE ALLEGEDLY FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19030494 ↗MalfunctionFeb 27, 2024Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY, WHEN THE PHYSICIAN TURNED THE GRIP TWICE TO SET IT, THE INNER NEEDLE SHOT OUT A LITTLE WHEN IT WAS SET FOR SECOND TIME AND THE DEVICE ALLEGEDLY COULD NOT ABLE TO COLLECT THE TISSUE. IT WAS FURTHER REPORTED THAT THE ARROW INDICATOR ON THE MAIN BODY WAS ALSO SET CORRECTLY AND THE PHYSICIAN INSERTED IT AND PRESSED THE FIRING BUTTON WITHOUT NOTICING THAT THE INNER NEEDLE WAS SLIGHTLY PROTRUDING AND THE TISSUE WAS ALLEGEDLY NOT COLLECTED. REPORTEDLY, THE PHYSICIAN SET IT AGAIN AND NOTICED THE PROBLEM. THE PROCEDURE COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18786337 ↗MalfunctionFeb 27, 2024Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PHYSICIAN TURNED THE GRIP TWICE TO SET IT, THE INNER NEEDLE ALLEGEDLY SHOT OUT A LITTLE WHEN IT WAS SET FOR SECOND TIME AND THE DEVICE ALLEGEDLY COULD NOT BE ABLE TO COLLECT TISSUE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18786269 ↗MalfunctionFeb 14, 2024Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE GRIP OF THE DEVICE ALLEGEDLY FAILED TO ROTATE WHEN TRIED TO SET THE INNER AND OUTER NEEDLES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704915 ↗MalfunctionDec 21, 2023Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information; Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information
IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY ALREADY ARMED AT THE OPENING AND DOES NOT WORK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18370663 ↗MalfunctionDec 11, 2023Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY FIRED BEFORE TWO TURNS OF THE GRIP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18299990 ↗MalfunctionDec 9, 2023Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING AN ECHO-GUIDED MAMMARY GLAND BIOPSY PROCEDURE, ON LOCKING THE INNER NEEDLE FOR THE SECOND TIME, THE OUTER CYLINDER ALLEGEDLY FIRED BEFORE THE GRIP WAS TURNED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18298163 ↗MalfunctionDec 5, 2023Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED ON ITS OWN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18272005 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 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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