EVIVA_1213-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15420045504998), received between Mar 7, 2018 and Sep 22, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860171 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN EVIVA PROCEDURE ON (B)(6) 2025, "NEEDLE TIP TWISTED AT NOTCH ON TISSUE SAMPLING. INITIAL SAMPLING SUCCESSFUL WITH SOME SPECIMEN. SECOND ROUND SAMPLING PRODUCED NO TISSUE SAMPLE AND WHEN WE WOUND THE NEEDLE OUT OF THE PATIENT BREAST, WE NOTICED THE NEEDLE TIP HAD TWISTED." IT IS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT/USER INJURY WAS REPORTED, AND NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767918 ↗
• MalfunctionJun 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE ON (B)(6) 2023, THE BIOPSY WENT FINE BUT AFTER PULLING THE NEEDLE OUT OF THE BREAST IT WAS BENT AND TWISTED. THE BIOPSY WENT FIND AND NO ABNORMAL SOUNDS WERE REPORTED ONLY RESISTANCE DURING THE ASPIRATION STAGE. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131574 ↗
• MalfunctionJan 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON JANUARY 4TH, 2023, AN EVIVA PROCEDURE WAS PERFORMED AND THE DOCTOR DISCOVERED THE NEEDLE BENT WHILE TRYING TO REMOVE IT FROM THE BREAST, THE DOCTOR WAS ABLE TO FULLY REMOVE IT FROM THE PATIENT'S BREAST WITHOUT HARM, AND THE PROCEDURE WAS COMPLETED SUCCESFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195899 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING AN EVIVA BIOPSY PROCEDURE 2 NEEDLES WERE USED ON A PATIENT AND NO SAMPLES COULD BE RETRIEVED DUE TO INSUFFICIENT VACUUM. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND TO RESCHEDULE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952581 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN EVIVA BIOPSY PROCEDURE 2 NEEDLES WERE USED ON A PATIENT NAD NO SAMPLES COULD BE RETRIEVED DUE TO INSUFFICIENT VACUUM. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND TO RESCHEDULE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952570 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE ON FEBRUARY 2ND, THE NEEDLE FAILED TO OBTAIN SAMPLES AND THE PATIENT BECAME UNWELL. THE PROCEDURE WAS ABORTED AT THIS POINT, AND IT WAS RESCHEDULED, PATIENT RECEIVED LOCAL ANESTHETIC AND AN INCISION, BUT NO SPECIMENS WERE OBTAINED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13571974 ↗
• MalfunctionApr 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY, AFTER TAKING 3-5 SPECIMENS, THE PATIENT COMPLAINED OF PAIN. WHEN ATTEMPTING ADDITIONAL SAMPLES THE PATIENT CONTINUED TO HAVE PAIN AND THE SPECIMEN PASSING THE TUBE SEEMED TO BE SMALLER THAN USUAL. A CONTROL PICTURE SHOWED THE DEFORMED NEEDLE AND A DECISION WAS MADE TO STOP THE PROCEDURE. DIFFICULTIES IN DRAWING THE NEEDLE OUT OF THE BREAST. NO SERIOUS INJURY REPORTED AND NO MEDICAL INTERVENTION REQUIRED. THIS EVENT OCCURED IN (B)(6) 2020, BUT WAS NOT REPORTED BY THE CUSTOMER TO HOLOGIC UNTIL (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain; Intraoperative Pain

  MAUDE report 11611181 ↗
• MalfunctionApr 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER TAKING SEVERAL SPECIMEN, THE PATIENT COMPLAINED OF PAIN IN THE BREAST AND THE SAMPLES BEING CUT WERE SMALLER THAN BEFORE. AFTER DRAWING THE NEEDLE BACK AND OUT OF THE BREAST, THE TIP OF THE NEEDLE WAS NOTED TO BE "BENT OR EVEN TWISTED." NO SERIOUS INJURY REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THIS EVENT OCCURRED IN (B)(6) 2021, BUT WAS NOT REPORTED BY THE CUSTOMER TO HOLOGIC UNTIL (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain; Intraoperative Pain

  MAUDE report 11611180 ↗
• MalfunctionApr 2, 2021Material Twisted/Bent; Material Twisted/Bent

  DURING A BIOPSY PROCEDURE, AFTER TAKING SEVERAL SPECIMENS, THE PATIENT COMPLAINED OF PAIN IN HER BREAST. AFTER DRAWING THE NEEDLE BACK AND OUT OF THE BREAST IT WAS NOTED THE TIP OF THE NEEDLE WAS "BENT OR EVENT TWISTED." NO SERIOUS INJURY REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THIS EVENT OCCURRED IN (B)(6) 2020, BUT WAS NOT REPORTED BY THE CUSTOMER TO HOLOGIC UNTIL 3/8/2021.

  Patient problems: Breast Discomfort/Pain; Intraoperative Pain

  MAUDE report 11611178 ↗
• MalfunctionDec 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE IT WAS DIFFICULT TO REMOVE THE NEEDLE. WHEN THE NEEDLE WAS REMOVED IT WAS NOTED TO BE BENT. THE PATIENT FELT DISCOMFORT DURING THE REMOVAL. ADDITIONAL INFORMATION RECEIVED NOTED, "PATIENT OUTCOME IS UNKNOWN AT THIS STAGE. SHE HAS NOT YET RECEIVED HER RESULTS SO I DON'T KNOW THE EXTENT OF ANY BRUISING."

  Patient problems: Discomfort

  MAUDE report 11020605 ↗
• MalfunctionAug 20, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY EXAM THE NEEDLE BENT AND A PORTION OF THE TIP DISLODGED. NO INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797222 ↗
• MalfunctionAug 2, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE PHYSICIAN PERFORMED A BREAST BIOPSY PROCEDURE ON (B)(6) 2018, AND THE PHYSICIAN HAD A LOT OF RESISTANCE AND HAD A DIFFICULT TIME REMOVING THE NEEDLE FROM THE BREAST. THEN THE NEEDLE WAS REMOVED IT WAS NOTED "TWISTED AND BENT" WHEN REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7741882 ↗
• MalfunctionMar 7, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PHYSICIAN PERFORMED AN EVIVA BREAST BIOPSY ON (B)(6) 2017, AND THE BIOPSY NEEDLE "BECAME TWISTED AND BENT". THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320424 ↗