MARQUEE MQ1410Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00801741097133), received between Jan 6, 2021 and Mar 5, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (18 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 29, 2025Self-Activation or Keying; Failure to Obtain Sample; Self-Activation or Keying; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT WITH IMAGING OF ECHOGRAPHY WITH NORMAL DENSITY OF LESION. DURING THE PROCEDURE, IT WAS REPORTED THAT DEVICE DOES NOT OBTAIN GOOD SAMPLES. IT WAS FURTHER REPORTED THAT THE PROBE WAS FIRED AUTOMATICALLY WHEN THE PROBE IS IN SEMIAUTOMATIC MODE. NO COAXIAL NEEDLES WERE USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412742 ↗
• MalfunctionOct 29, 2025Self-Activation or Keying; Failure to Obtain Sample; Self-Activation or Keying; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING THE MARQUEE INSTRUMENT WITH IMAGING OF ECHOGRAPHY WITH NORMAL DENSITY OF LESION. DURING THE PROCEDURE, IT WAS REPORTED THAT DEVICE DOES NOT OBTAIN GOOD SAMPLES. IT WAS FURTHER REPORTED THAT THE PROBE WAS FIRED AUTOMATICALLY WHEN THE PROBE IS IN SEMIAUTOMATIC MODE. NO COAXIAL NEEDLES WERE USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411896 ↗
• MalfunctionApr 22, 2025Break; Crack; Break; Crack

  IT WAS IDENTIFIED BASED ON SAMPLE EVALUATION; THE PENETRATION DEPTH MARKER APPEARED TO BE DETACHED FROM THE DEVICE. IT WAS FURTHER IDENTIFIED THAT A CRACK WAS NOTED TO THE DEPTH ADJUSTMENT PLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883876 ↗
• MalfunctionJan 29, 2025Break; Crack; Difficult to Insert; Break; Crack; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL TISSUE, THE NEEDLE OF THE PRODUCT ALLEGEDLY DIDN'T PENETRATE THE TISSUE PROPERLY. IT WAS FURTHER REPORTED THAT NOTCH LENGTH SELECTION PARTS OF PRODUCT HAD FALLEN OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261442 ↗
• MalfunctionJan 10, 2025Crack; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Crack; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE GUN WAS ALLEGEDLY NOT REMOVED FROM PATIENT AFTER SHOOTING. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS COMPLETELY BENT FROM THE GUIDE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126880 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE SMALL WHITE SQUARE PLASTIC PIECE HAS ALLEGEDLY BROKEN OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946996 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE SMALL WHITE SQUARE PLASTIC PIECE HAS ALLEGEDLY BROKEN OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946992 ↗
• MalfunctionAug 7, 2024Nonstandard Device; Failure to Prime; Detachment of Device or Device Component; Nonstandard Device; Failure to Prime; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE APERTURE ALLEGEDLY STUCK INSIDE THE OUTER CANNULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935491 ↗
• MalfunctionJul 17, 2024Self-Activation or Keying; Firing Problem; Self-Activation or Keying; Firing Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DOCTOR PRESSED SEMI-AUTOMATIC BUTTON BUT AUTOMATIC BUTTON WAS ALLEGEDLY WORKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768050 ↗
• MalfunctionJun 6, 2024Nonstandard Device; Failure to Prime; Failure to Fire; Detachment of Device or Device Component; Nonstandard Device; Failure to Prime; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO SLIDE TO OPEN THE TROUGH TO REMOVE THE SAMPLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474523 ↗
• MalfunctionApr 15, 2024Failure to Prime; Device Contamination with Chemical or Other Material; Failure to Prime; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO PRIME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103296 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH NORMAL SCATTERED DENSITY TISSUE, AS THE DEVICE WAS BEING REMOVED, THE NEEDLE OF THE DEVICE ALLEGEDLY KEPT GETTING LONGER AND DID NOT COMPLETELY COME OUT OF THE COAXIAL. IT WAS FURTHER REPORTED THAT THE CUTTING NEEDLE WITH THE STRIPS THAT COVERS THE TROUGH WAS ALLEGEDLY FOUND TO DETACHED FROM THE BIOPSY UNIT. REPORTEDLY, THE WHITE PORTION OF THE BIOPSY DEVICE AND THE END OF THE CUTTING NEEDLE WERE HELD IN ORDER TO PREVENT IT FROM COMPLETELY DETACHING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18795345 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649060 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649058 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649057 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649056 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648327 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648325 ↗
• MalfunctionFeb 6, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THERE WAS ALLEGEDLY A LOT OF WATER DAMAGE AND SOME OF THE NEEDLE TRAYS WERE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648324 ↗
• MalfunctionOct 6, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY FIRED INSIDE THE PATIENT BEFORE THE PHYSICIAN TOOK THE ACTION TO FIRE. IT WAS FURTHER REPORTED THAT THE NEEDLE SPONTANEOUSLY FIRED IN THE PATIENT'S BREAST AND WHEN REMOVED, THE SAMPLE NOTCH WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884585 ↗
• MalfunctionOct 6, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY FIRED INSIDE THE PATIENT BEFORE THE PHYSICIAN TOOK THE ACTION TO FIRE. IT WAS FURTHER REPORTED THAT THE NEEDLE SPONTANEOUSLY FIRED IN THE PATIENT'S BREAST AND WHEN REMOVED, THE SAMPLE NOTCH WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884584 ↗
• MalfunctionOct 6, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY FIRED INSIDE THE PATIENT BEFORE THE PHYSICIAN TOOK THE ACTION TO FIRE. IT WAS FURTHER REPORTED THAT THE NEEDLE SPONTANEOUSLY FIRED IN THE PATIENT'S BREAST AND WHEN REMOVED, THE SAMPLE NOTCH WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884582 ↗
• MalfunctionOct 6, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY FIRED INSIDE THE PATIENT BEFORE THE PHYSICIAN TOOK THE ACTION TO FIRE. IT WAS FURTHER REPORTED THAT THE NEEDLE SPONTANEOUSLY FIRED IN THE PATIENT'S BREAST AND WHEN REMOVED, THE SAMPLE NOTCH WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884577 ↗
• MalfunctionOct 6, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY FIRED INSIDE THE PATIENT BEFORE THE PHYSICIAN TOOK THE ACTION TO FIRE. IT WAS FURTHER REPORTED THAT THE NEEDLE SPONTANEOUSLY FIRED IN THE PATIENT'S BREAST AND WHEN REMOVED, THE SAMPLE NOTCH WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884511 ↗