EVIVA_0913-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 15420045504974), received between Dec 7, 2017 and Sep 30, 2026 — classified as 85 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (45 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 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Open or Close

  The following was reported by the user site on (b)(6)2026, "We performed a stereotactic biopsy today. The first standard needle that we used made a strange noise when turning the machine on. The needle passed all tests initially but had a strange noise still while completing the QC needle test. We decided to retry the whole test setup. When we were going back through the test the second time, the trough of the needle wouldn't open or close properly. We decided not to use that needle and open a new one since that one seemed to not function properly." No patient and/or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942574 ↗
• InjurySep 30, 2026Failure to Obtain Sample

  It was reported by the user site that during a breast biopsy procedure, "the instrument wouldn't sample correctly. It took a very small tissue sample, then would delay for an extended period, then restart with another very small tissue sample. The saline was running correctly but the probe wouldn't sample." No patient and/or user harm was reported; however, an additional device was required to successfully complete the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941895 ↗
• InjurySep 30, 2026Failure to Obtain Sample

  It was reported by the user site that despite the device passing needle testing prior to the breast biopsy procedure, "Once we tried taking a sample, the needle did not work. It did not take a sample/cut." No patient or user harm was reported; however, an additional device was required to successfully complete the breast biopsy procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941874 ↗
• MalfunctionSep 30, 2026Failure to Cycle

  It was reported by the user site that prior to a procedure, the user was "unable to arm the needle and it did not make the popping sound when arming. The trough was also open at the end of testing." No patient or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941812 ↗
• MalfunctionSep 28, 2026Failure to Cycle

  It was reported by the user site that during testing of the device, "the slide would remain open." Customer outreach confirmed that "When you put the probe into prefire, the trough is normally closed, but in this particular instance, the trough was still around a quarter to half way open." The issue was identified prior to the procedure and prior to patient use. The procedure was completed successfully using another device. No patient or user harm was reported, and no additional medical or surgical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917673 ↗
• InjurySep 22, 2026Failure to Obtain Sample

  It was reported by the user site that during a breast biopsy procedure "the vacuum needle could not suction any breast tissue out despite the fact that it passed the console test with saline flush." It is reported that the procedure was successfully completed with another device. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854055 ↗
• MalfunctionSep 22, 2026Mechanical Jam

  It was reported by the user site that during testing of the device, "the cutting mechanism did not work. It got stuck halfway and wouldn't move." No patient or user harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853927 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853772 ↗
• InjurySep 22, 2026Failure to Obtain Sample

  It was reported by the user site that the "Saline "[was]" not going through the needle when the needle is in the breast when obtaining tissue samples." Customer outreach confirmed that tissue could not be adequately acquired from the target area with the initial device and that the procedure was successfully completed using another device. No patient or user harm was reported. The customer reported issues with 3 needles, this record captures the 3rd.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853606 ↗
• MalfunctionSep 22, 2026Failure to Cycle

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853417 ↗
• InjurySep 22, 2026Failure to Obtain Sample

  It was reported by the user site that "Saline "[was]" not going through the needle when the needle is in the breast when obtaining tissue samples." Customer outreach confirmed that tissue could not be adequately acquired from the target area with the initial device and that the procedure was aborted. They stated "the patient was given a short term follow up because they did not want to continue the procedure".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853254 ↗
• InjurySep 22, 2026Failure to Obtain Sample

  It was reported by the user site that, "Saline "[was]" not going through the needle when the needle is in the breast when obtaining tissue samples." Customer outreach confirmed that tissue could not be adequately acquired from the target area with the initial device and that the procedure was successfully completed using another device. No patient or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853113 ↗
• InjurySep 21, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844467 ↗
• InjurySep 21, 2026Failure to Obtain Sample

  It was reported by the user site that "After one biopsy sample, the device stopped working. Completed biopsy with a different device." As a result, tissue could not be acquired from the target area with the initial device. The procedure was completed using another device. No patient or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843575 ↗
• MalfunctionSep 21, 2026Failure to Cycle

  It was reported by the user site that the device's "Cutting chamber would not close." The issue was identified prior to the procedure and prior to patient use. No patient or user harm was reported, and no additional medical or surgical intervention was required. Customer outreach confirmed the issue was identified prior to the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839251 ↗
• InjurySep 21, 2026Failure to Obtain Sample

  It was reported by the user site that during a biopsy procedure, "while taking samples, the needle experienced a long continuous suction sound while taking a sample in the 6:00 position." The customer further reported that a "Red error light did go off" and that attempts to lavage and continue the biopsy were unsuccessful due to the error condition. The customer reported that "We were able to get a sample from every other number EXCEPT for the 6:00." A new needle was utilized, and "Successful sample retrieved at 6:00 with a new needle." No patient or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839206 ↗
• InjuryAug 7, 2026Failure to Cut

  It was reported by the user site that during a breast biopsy procedure the device wasn't cutting. Additional information obtained from the user site confirmed that after targeting, firing, and attempting to obtain a sample, "the doctor identified that the needle was not cutting when using the foot pedal." The customer also confirmed "The patient was rescheduled and returned the next week to complete the procedure." Additionally, the customer confirmed the needle in question was from lot E26DE0RU. No further information is availbe at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175564 ↗
• MalfunctionJul 27, 2026Material Twisted/Bent

  The customer reported there was a long cutting time during the last (6th) sample. It was reported that during lavage to collect the samples, there was some minor resistance on rotating the needle to collect samples. The patient reportedly felt an increased pressure in her breast which she said was tolerable, but not painful. Upon imaging the sample, only a few microcalcifications were seen. The customer reported as the patient "felt fine," additional samples were taken. 3 more samples were taken with the same reported resistance when turning the notch as the initial samples. As the patient reportedly felt an increased pressure in her breast again but no pain, the needle was withdrawn. The tip of the needle was then observed to be bent. The consultant radiologist withdrew the needle from the breast carefully. The needle was stuck to the introducer as it was bent and could not be withdrawn through the introducer. The needle and introducer were removed as a unit from the patient. A new needle pack was opened to get another plastic introducer sheath in order to insert a marker clip, and ended the procedure. The was no report of patient or user harm. No further information is available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045708 ↗
• InjuryJun 9, 2026Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY ON (B)(6) 2026 WITH AN EVIVA DEVICE THAT A PATIENT REQUIRED ADDITIONAL SURGICAL AND MEDICAL INTERVENTION. THE REPORT STATES THE "PATIENT HAD TO STAY ON TABLE FOR AN EXTENDED AMOUNT OF TIME WITH 3 SITES IN THE BREAST CUT, TO GET SMALL SAMPLE. PT HAD EXTRA IMAGING DONE AS WELL". THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. THE REPORTER STATES THERE WAS PATIENT HARM IN THAT THEY REQUIRED 3 BIOPSY SITES, AND ADDITIONAL IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443634 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT EXPERIENCED A SYNCOPAL EPISODE WHILE HAVE A BREAST BIOPSY PROCEDURE WITH AN EVIVA BIOPSY DEVICE. THE USER SITE REPORTS "DURING A VACUUM PROCEDURE, PATIENT FAINTED AFTER 5 SAMPLES ACQUIRED; WHILE THE CONSULTANT WAS REMOVING THE NEEDLE FROM THE BREAST PATIENT, SHE JERKED BACK AND THE TIP OF THE NEEDLE CUT THE SKIN. SURGEON WAS CALLED AND GAVE A FEW STITCHES TO STOP THE BLEEDING." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Laceration(s); Syncope/Fainting

  MAUDE report 25362055 ↗
• InjuryJun 1, 2026Suction Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY USING AN EVIVA SYSTEM ON(B)(6) 2026 THAT THE "NEEDLE PASSED INITIAL TEST BUT FAILED SUCTION AND TO FULLY OPEN APERTURE DURING BIOPSY." ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER, IN WHICH IT WAS REPORTED THAT THE "PATIENT WAS NOT HARMED BY THE NEEDLE ITSELF, HOWEVER, THE PATIENT ENDED UP WITH [A] RIB FRACTURE POSSIBLY DUE TO LYING PRONE FOR AN EXTENDED PERIOD OF TIME. ADDITIONAL X-RAY IMAGES [WERE] DONE TO CONFIRM [THE] FRACTURE." IT WAS FURTHER REPORTED BY THE CUSTOMER THAT THE PATIENT PROCEDURE WAS ABORTED, AND ANOTHER BIOPSY ATTEMPT WILL BE MADE UPON HEALING OF THE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25347923 ↗
• MalfunctionJun 1, 2026

  FROM STAFF: DURING THE SET-UP PROCESS OF THE STEREOTACTIC BIOPSY, THE EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM DID NOT PASS THE TEST PRIME AND FIRE. THE BREAST BIOPSY NEEDLE WAS REMOVED, AND A NEW NEEDLE WAS OPENED AND THE SET-UP PROCESS WAS SUCCESSFUL. LOT: E26A26RF. MANUFACTURER INVESTIGATING. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, EVIVA_0913-20 (PER SITE REPORTER), [REDACTED].

  Patient problems: Insufficient Information

  MAUDE report 25347564 ↗
• MalfunctionJun 1, 2026

  FROM STAFF: WHILE SETTING UP THE EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM THE NEEDLE DID NOT PASS THE SET-UP STAGE ON THE FIRST TRY. THEN DURING THE TEST STAGE OF SET-UP, THE BIOPSY WINDOW DID NOT OPEN AND CLOSE APPROPRIATELY. AT THAT TIME THE BIOPSY DEVICE WAS DISCONNECT FORM THE PEARL MACHINE AND A NEW STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM WAS OPENED AND SET-UP FOR THE PROCEDURE. THE MANUFACTURER IS INVESTIGATING AS THIS HAS BEEN AN ISSUE WITH MULTIPLE DEVICES. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, EVIVA_0913-20 (PER SITE REPORTER). INVESTIGATING AS THIS HAS BEEN AN ISSUE WITH MULTIPLE DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25347559 ↗
• MalfunctionJun 1, 2026

  FROM STAFF: THE PATIENT WAS SET-UP TO HAVE A STEREOTACTIC BIOPSY DONE OF HER BREAST. DURING THE BIOPSY THE EVIVA BREAST BIOPSY NEEDLE AND ATEC BREAST BIOPSY MACHINE WOULD NOT FUNCTION CORRECTLY. BIOPSY SETTING APPEARED TO BE WORKING BUT THERE WERE NO SPECIMENS BEING COLLECTED. TROUBLE SHOOTING OCCURRED- SUCTION FUNCTION WAS CHECKED, SUCTION CANISTER WAS REPLACED, THE SALINE BAG WAS SQUEEZED TO TRY AND MOVE POSSIBLE SPECIMEN PIECES THROUGH THE TUBING, THE MACHINE WAS TURNED OFF AND BACK ON AND ALL PARTS WERE CHECKED AGAIN WHILE NEEDLE WAS INSIDE PATIENT'S BREAST. AFTER THAT SALINE WAS STILL NOT TRAVELING THROUGH THE TUBING. PROCEDURE WAS ENDED AT THIS POINT BY THE RADIOLOGIST AND AN ATTEMPT TO REMOVE SPECIMENS FROM NEEDLES WAS MADE AND SENT TO THE LAB. MANUFACTURER INVESTIGATING. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, EVIVA_0913-20 (PER SITE REPORTER), INVESTIGATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347496 ↗
• MalfunctionMay 19, 2026Firing Problem; Separation Problem

  IT WAS REPORTED BY THE USER THAT DURING AN EVIVA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, "DURING POST FIRE, THE NEEDLE FIRED BACKWARDS. THEN TWIST KNOB FELL OFF AND NEEDLE ADVANCED FORWARD INTO THE PATIENT." NO PATIENT HARM WAS REPORTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222061 ↗