MARQUEERecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one MARQUEE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 219
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 3
We found 26 models of MARQUEE by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 219 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Sep 25, 2026 — classified as 18 injuries, 201 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (67 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
MARQUEE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 30, 2024Open, Classified
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
Z-0467-2025 · Root cause: Process change control · names 4 of these models · Recall details · FDA record ↗
- Aug 10, 2023Open, Classified
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Z-0027-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jan 14, 2021Terminated
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Z-1289-2021 · Root cause: Process control · names 24 of these models · Recall details · FDA record ↗
Most reported MARQUEE problems
Device problems
- Difficult to Remove67
- Break36
- Material Twisted/Bent34
- Failure to Fire33
- Device-Device Incompatibility31
- Self-Activation or Keying24
- Device Contamination with Chemical or Other Material20
- Adverse Event Without Identified Device or Use Problem18
Patient problems
- No Clinical Signs, Symptoms or Conditions192
- No Consequences Or Impact To Patient8
- Hemorrhage/Blood Loss/Bleeding7
- Pneumothorax6
- Hematoma3
- Unspecified Tissue Injury2
- Foreign Body In Patient1
- No Patient Involvement1
MARQUEE models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MARQUEE MQK2016INSTRUMENT, BIOPSY2 recalls28 reports
- MARQUEE MQK1210INSTRUMENT, BIOPSY2 recalls11 reports
- MARQUEE MQ1210INSTRUMENT, BIOPSY2 recalls9 reports
- MARQUEE MQ1410INSTRUMENT, BIOPSY1 recall51 reports
- MARQUEE MQK1213INSTRUMENT, BIOPSY2 recalls1 report
- MARQUEE MQ1213INSTRUMENT, BIOPSY2 recalls0 reports
- MARQUEE MQK1410INSTRUMENT, BIOPSY1 recall22 reports
- MARQUEE MQ1610INSTRUMENT, BIOPSY1 recall21 reports
- MARQUEE MQ1820INSTRUMENT, BIOPSY1 recall19 reports
- MARQUEE MQ1816INSTRUMENT, BIOPSY1 recall17 reports
- MARQUEE MQ1825INSTRUMENT, BIOPSY1 recall13 reports
- MARQUEE MQK1825INSTRUMENT, BIOPSY1 recall9 reports
- MARQUEE MQ1413INSTRUMENT, BIOPSY1 recall4 reports
- MARQUEE MQ1810INSTRUMENT, BIOPSY1 recall4 reports
- MARQUEE MQK1610INSTRUMENT, BIOPSY1 recall3 reports
- MARQUEE MQK1810INSTRUMENT, BIOPSY1 recall2 reports
- MARQUEE MQK1816INSTRUMENT, BIOPSY1 recall1 report
- MARQUEE MQ1416INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQ1616INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQ1620INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQK1413INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQK1416INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQK1820INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQK2010INSTRUMENT, BIOPSY1 recall0 reports
- MARQUEE MQ2016INSTRUMENT, BIOPSY3 reports
- MARQUEE MQ2010INSTRUMENT, BIOPSY1 report
Recent MARQUEE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Difficult to Remove
On (b)(6) 2026, a male patient underwent an ultrasound guided prostate biopsy procedure using a Marquee biopsy instrument via a transrectal approach. During the procedure, the biopsy cannula bent after four tissue samples were obtained. A second instrument with the same reference number and lot number was subsequently used; however, the same issue recurred, with the biopsy cannula bending after four tissue samples were collected. It was further reported that difficulty was encountered while withdrawing the bent cannula from the patient. The procedure was ultimately completed using a third device. The patient experienced discomfort and pain, for which 1percent lidocaine was administered. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893720 ↗MalfunctionSep 25, 2026Difficult to Remove
On (b)(6)2026, a male patient underwent an ultrasound guided prostate biopsy procedure using a Marquee biopsy instrument via a transrectal approach. During the procedure, the biopsy cannula bent after four tissue samples were obtained. A second instrument with the same reference number and lot number was subsequently used; however, the same issue recurred, with the biopsy cannula bending after four tissue samples were collected. It was further reported that difficulty was encountered while withdrawing the bent cannula from the patient. The procedure was ultimately completed using a third device. The patient experienced discomfort and pain, for which 1percent lidocaine was administered. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893713 ↗MalfunctionSep 23, 2026Difficult to Remove; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guided lung biopsy procedure through normal tissue density using the Marquee device. During the procedure, the needle was found to be bent, specifically involving the stylet. Difficulty was also encountered while removing the product from the patient. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865881 ↗MalfunctionMay 5, 2026Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INSTRUMENT NEEDLES BECAME BROKEN DURING USE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25076581 ↗MalfunctionMay 5, 2026Break
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A MARQUEE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INSTRUMENT NEEDLES BECAME BROKEN DURING USE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25076579 ↗MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064768 ↗MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064767 ↗MalfunctionMay 4, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064766 ↗MalfunctionApr 27, 2026Break; Failure to Obtain Sample; Firing Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MARQUEE DEVICE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY MISFIRED AND FAILED TO OBTAIN A SAMPLE. IT WAS FURTHER REPORTED THAT A PART OF THE DEVICE CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994263 ↗MalfunctionApr 27, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, A MALE PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING THE MARQUEE DEVICE. POST THE PROCEDURE, THERE WAS INCREASED RECTAL BLEEDING. REPORTEDLY, THE BLEEDING WAS CONTROLLED PRIOR TO DISCHARGE FROM THE CLINIC. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994070 ↗MalfunctionMar 17, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE BY USING MARQUEE DEVICE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE ITEM ALLEGEDLY FELL APART WHILE SETTING UP. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615700 ↗MalfunctionMar 5, 2026Nonstandard Device; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT. IT WAS REPORTED THAT DURING THE SECOND BIOPSY ATTEMPT, THE CANNULA (GRADUATED PORTION) REMAINED INSIDE THE BREAST. A SUBSEQUENT ATTEMPT WAS MADE OUTSIDE THE BREAST, DURING WHICH THE TROCAR ALLEGEDLY RELEASED UNEXPECTEDLY AND SHOT TOWARD THE WALL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24517271 ↗MalfunctionMar 5, 2026Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING MARQUEE DEVICE. DURING THE PROCEDURE, THE STYLET COULDN'T T BE PULLED OUT AFTER INSERTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516894 ↗MalfunctionFeb 12, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDANCE LUNG BIOPSY PROCEDURE THROUGH SOFT DENSITY TISSUE USING MARQUEE KIT INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE WAS BENT, AND NEEDLE WAS VERY DIFFICULT TO REMOVE FROM THE PATIENT. COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319981 ↗MalfunctionJan 13, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY-GUIDED LUNG BIOPSY THROUGH SOFT DENSITY TISSUE USING THE MARQUEE INSTRUMENT. DURING THE PROCEDURE, THE STYLET PART OF THE NEEDLE WAS BENT AND DIFFICULT TO REMOVE FROM THE PATIENT. A COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050674 ↗
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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