VACORARecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of VACORA by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Aug 9, 2023 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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
Most reported VACORA problems
Device problems
- Detachment of Device or Device Component13
- Device Contamination with Chemical or Other Material3
- Accessory Incompatible2
- Bent1
- Break1
- Device Markings/Labelling Problem1
- Difficult to Remove1
- Failure to Calibrate1
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions6
- No Patient Involvement3
VACORA models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VACORA® VB14116USINSTRUMENT, BIOPSY9 reports
- VACORA® VB10118INSTRUMENT, BIOPSY4 reports
- VACORA® VB14116INSTRUMENT, BIOPSY2 reports
- VACORA® VB10118USINSTRUMENT, BIOPSY2 reports
- VACORA® VC14138MRSINSTRUMENT, BIOPSY2 reports
- VACORA® VC10118PINSTRUMENT, BIOPSY1 report
- VACORA® VC10140INSTRUMENT, BIOPSY1 report
Recent VACORA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2023Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, ONCE THE NEEDLE WAS PLACED, IT ALLEGEDLY DETACHED A SMALL PIECE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486490 ↗MalfunctionFeb 24, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE INSTRUCTION IN THE PRODUCT LABELING APPEARED TO BE SMALL AND UNCLEAR. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13589749 ↗MalfunctionOct 27, 2021Accessory Incompatible; Detachment of Device or Device Component; Accessory Incompatible; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DISTANCE RING ON THE INTRODUCER WAS CONNECTED AND THE INTRODUCER ALLEGEDLY COULD NOT BE MOVED EVEN AFTER MOISTURIZING IT. IT WAS FURTHER REPORTED THAT THE CONNECTION WAS SO FIRM THAT THE WHITE PLASTIC PART WAS STRIPPED OFF AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12702163 ↗MalfunctionOct 27, 2021Accessory Incompatible; Detachment of Device or Device Component; Accessory Incompatible; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DISTANCE RING ON THE INTRODUCER WAS CONNECTED AND THE INTRODUCER ALLEGEDLY COULD NOT BE MOVED EVEN AFTER MOISTURIZING IT. IT WAS FURTHER REPORTED THAT THE CONNECTION WAS SO FIRM THAT THE WHITE PLASTIC PART WAS STRIPPED OFF AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12702130 ↗MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN BREAST BIOPSY PROCEDURE, THE TUBE ALLEGEDLY DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11919243 ↗MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE CONNECTING TUBE ALLEGEDLY DETACHED FROM THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11452399 ↗MalfunctionOct 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB14116US BIOPSY INSTRUMENT ALLEGEDLY DETACHED. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10759398 ↗MalfunctionOct 22, 2020Failure to Calibrate; Device Contamination with Chemical or Other Material; Failure to Calibrate; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB10118US BIOPSY INSTRUMENT ALLEGEDLY FAILED TO CALIBRATE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION DID NOT INVOLVE A PATIENT. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10722924 ↗MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VB14116US BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED TUBE DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283226 ↗MalfunctionApr 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL VC10118US BIOPSY INSTRUMENT ALLEGEDLY A RED PLASTIC PIECE WAS FOUND ON THE TIP OF THE NEEDLE WHEN OPENING THE PACKAGE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE ONE DID NOT INVOLVED PATIENTS WITH NO REPORTED PATIENT CONTACT. THE PATIENTS AGE AND WEIGHT NOT PROVIDED. OF THE REPORTED PATIENTS WAS FEMALE.
Patient problems: No Patient Involvement
MAUDE report 8489070 ↗MalfunctionApr 5, 2019Mechanical Problem; Mechanical Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL VB10118 BIOPSY INSTRUMENT ALLEGEDLY MOVED UNEXPECTEDLY. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE ONE EVENTS INVOLVED PATIENTS WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE AND WEIGHT NOT PROVIDED. OF THE REPORTED PATIENTS WAS FEMALE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8489069 ↗MalfunctionSep 26, 2018Failure to Cycle; Difficult to Remove; Failure to Cycle; Difficult to Remove
IT WAS REPORTED THAT DURING A BIOPSY OF THE THIGH MUSCLE, THE PROBE ALLEGEDLY STOPPED CYCLING WHILE INSIDE THE PATIENT, AND THE DEVICE ALLEGEDLY WAS UNABLE TO BE REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS TROUBLESHOT WHILE INSIDE THE PATIENT AND BEGAN WORKING AGAIN. THE DEVICE WAS THEN ABLE TO BE REMOVED FROM THE PATIENT AND THE TISSUE SAMPLE WAS OBTAINED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7912100 ↗MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT UPON VISUAL INSPECTION DURING R&D TESTING OF THE DEVICE, THE DEVICE WAS ALLEGEDLY OBSERVED TO HAVE FOREIGN MATERIAL ON THE NEEDLE TIP WHILE THE TYVEK LID WAS STILL INTACT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7660670 ↗MalfunctionMay 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY, THE VACUUM TUBING CONNECTING THE NEEDLE AND THE VACUUM CHAMBER POPPED OPEN AND SPRAYED BLOOD. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AD A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7541834 ↗MalfunctionMay 11, 2018Bent; Material Twisted/Bent; Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY, THE COAXIAL CANNULA WAS ALLEGEDLY BENT INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE ENOUGH SAMPLES TO COMPLETE THE PROCEDURE. REPORTEDLY, THE COAXIAL WAS UNABLE TO BE USED TO GUIDE THE MARKER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7509240 ↗
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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