EVIVA 0913-12TRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 15420045505339), received between Dec 28, 2017 and Sep 22, 2026 — classified as 14 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Failure to Obtain Sample

  It was reported by the user site that the device was, "unable to lavage and get good tissue sampling. The problem was with the absorbing and cutting mechanism." Customer outreach confirmed that "The issue was identified after the needle had been inserted into the patient" and "The needle was replaced with a new one, and the procedure was subsequently completed using the replacement needle". The "tissue specimen obtained was incomplete and consisted only of small tissue fragments. And could not be Lavage." prior to changing the needle and successfully completing the procedure. Serious injury reporting is being submitted due to tissue not being acquired from the target requiring an additional needle insertion to complete the biopsy procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853309 ↗
• InjurySep 21, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845541 ↗
• InjuryJul 27, 2026Break

  It was reported that during a breast biopsy there was a "Broken plastic introducer sheath." The customer reported the procedure was completed successfully with the same device. They confirmed there was no harm, and no medical or surgical intervention required. Customer outreach confirmed "physician was not able to deployed the first marker as the sheath was broken, however they changed the marker to direct insertion with needle holder and managed to insert via the same incision site that was created initially for the VAB by the Eviva needle...thus marker placement did not require additional surgical intervention". No further information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045697 ↗
• MalfunctionJun 8, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING BREAST BIOPSY ON (B)(6) 2026 WITH AN EVIVA DEVICE THAT THE NEEDLE "WAS ¿STUCK¿ IN BREAST IN OPEN POSITION." THE PROCEDURE WAS REPORTED TO BE "COMPLETED AND CALCS RETRIEVED". THERE WAS NO REPORT OF PATIENT/USER HARM, OR ADDITIONAL INTERVENTION. CUSTOMER OUTREACH WAS PERFORMED, BUT THERE WAS NO RESPONSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE IS A REPORTING PRECEDENT FOR A NEEDLE BEING STUCK IN THE BREAST FOR THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428925 ↗
• InjuryJun 5, 2026Failure to Obtain Sample

  IT WAS REPORTED BY THE USER THAT DURING AN EVIVA BIOPSY PROCEDURE ON (B)(6) 2026, "WE PLACED A SECOND NEEDLE THAT ALSO LOST SUCTION MID CASE. DID TRY A THIRD NEEDLE AND WAS ABLE TO FINISH THE CASE. WE ARE NOT SURE IF WE LOST SUCTION OR IF THE NEEDLE DID NOT COMPLETELY FIRE." ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER, IN WHICH IT WAS REPORTED THAT A SECOND SKIN INCISION TO THE PATIENT WAS REQUIRED IN ORDER TO COMPLETE THE PROCEDURE. INJURY MDR IS BEING SUBMITTED DUE TO THE ADDITIONAL SURGICAL INTERVENTION OF A SECOND SKIN INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409481 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  IT IS REPORTED THAT ON (B)(6) 2026 THE CUSTOMER WAS IN THE PROCESS OF COMPLETING A BIOPSY AND "OPENED A EVIVA 9G 12MM STEREO NEEDLE AND IT WAS BENT". THE CUSTOMER WAS UNABLE TO DO THE PROCEDURE, AND HAD NO ADDITIONAL PETITE NEEDLES AVAILABLE. THE PROCEDURE WAS ABORTED AND THEY HAD NO FURTHER NEEDLES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216915 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED BY THE USER SITE THAT DURING AN EVIVA BREAST BIOPSY ON (B)(6) 2026, THE "INTRODUCER BROKE APART, PART OF IT WAS STUCK ON THE NEEDLE WHEN THE TECHNOLOGIST REMOVED IT FOR MARKER PLACEMENT. RADIOLOGIST WAS ABLE TO PUT THE PIECES BACK INTO THE INTRODUCER AND PROCEED WITH PLACING THE MARKER." NO PATIENT HARM WAS REPORTED, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, AND NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651965 ↗
• MalfunctionMar 20, 2026Material Twisted/Bent

  IT WAS REPORTED THAT AN EVIVA BREAST BIOPSY PROCEDURE WAS COMPLETED ON A PATIENT ON (B)(6) 2026. THE USER REPORTS THAT SAMPLES OF BREAST TISSUE WERE COLLECTED; HOWEVER, WHEN REMOVING THE DEVICE PRIOR TO INSERTING THE MARKER, THE "TECHS HAD A DIFFICULT TIME." IT IS FURTHER REPORTED THAT THE "END OF THE SHEATH WAS CRUMPLED AND LOOKED DAMAGED." THERE WAS NO REPORTED PATIENT HARM, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649263 ↗
• InjuryMar 9, 2026Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN EVIVA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE RADIOLOGIST ACQUIRED EIGHT CORE SAMPLES; HOWEVER, ONLY ONE SAMPLE WAS ACTUALLY OBTAINED. IT IS REPORTED THAT VERY LITTLE TISSUE WAS ACQUIRED AND NO CALCIFICATIONS WERE PRESENT. THE USER SITE REPORTS THAT THE PATIENT PROCEDURE WAS ABORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547458 ↗
• MalfunctionFeb 26, 2026Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT AT THE CONCLUSION OF AN EVIVA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE USER ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT'S BREAST; HOWEVER, "THE NEEDLE GOT STUCK." IT IS REPORTED THAT THE USER HAD TO REMOVE BOTH THE INTRODUCER AND NEEDLE TOGETHER IN ORDER TO REMOVE THE NEEDLE FROM THE BREAST. THE USER FURTHER REPORTS THAT ONCE THE INTRODUCER WAS REMOVED, IT APPEARED "BENT/SQUISHED." NO PATIENT HARM WAS REPORTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462255 ↗
• MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EVIVA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, "THE ADAPTER TO THE HAND PIECE WAS DEFECTIVE AND THE BIOPSY MARKER WAS NOT ABLE TO BE PLACED THROUGH IT." IT WAS REPORTED THAT THE USER WAS ABLE TO SUCCESSFULLY COMPLETE THE BIOPSY PROCEDURE AND MARKER PLACEMENT BY OPENING AND USING ANOTHER DEVICE. NO PATIENT/USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456362 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE PREPARING FOR AN EVIVA BIOPSY PROCEDURE ON (B)(6) 2025, THE DEVICE WAS TESTED AND NO VACUUM FORMED. IT IS REPORTED THAT AIR COULD BE HEARD ESCAPING FROM THE CONNECTION BETWEEN THE TUBING AND THE NEEDLE AND THE INITIAL TEST FAILED. THE USER REPORTS THAT THE TUBING WAS PRESSED INTO THE NEEDLE AND THE DEVICE THEN PASSED TESTING. THE USER REPORTS THAT THE PROCEDURE WAS STARTED; HOWEVER, DURING THE PROCEDURE, THE USER WAS UNABLE TO LAVAGE THE DEVICE. THEREFORE, IT IS REPORTED, THAT AFTER ONE BIOPSY SAMPLE, THE PROCEDURE WAS ABORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532628 ↗
• InjuryJun 11, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT ON (B)(6), AN EVIVA PROCEDURE WAS PERFORMED AND THE NEEDLE WAS INSERTED INTO THE BREAST, AFTER TAKING SOME, NON-REPRESENTATIVE PROBES THE NEEDLE WAS NO LONGER ABLE TO CREATE A VACUUM FOR TISSUE SAMPLES, SO FURTHER SAMPLING WAS NOT POSSIBLE. THE PROCEDURE WAS ABORTED. THE FINDING REMAINED IN THE CHEST AND IS NOW BEING REMOVED SURGICALLY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509877 ↗
• InjuryFeb 2, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) DURING AN ATEC PROCEDURE THE TECH HEARD A LEAK DURING THE PROCEDURE AND THE CORES WERE TOO SMALL FOR DIAGNOSTIC USE. SYSTEM WAS REBOOTED AND THE NEEDLE REINSERTED AND THE PROCEDURE COULD NOT BE COMPLETED. SYSTEM WAS EXAMINED AND PASSED ALL TESTS, NO SUCTION ISSUES FOUND. PATIENT WILL NEED TO RETURN FOR 2ND PROCEDURE TO OBTAIN THE SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631242 ↗
• MalfunctionNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EVIVA PROCEDURE ON (B)(6) 2023, THE BIOPSY WAS COMPLETED AND CALCIFICATIONS WERE ABLE TO BE OBTAINED. POST PROCEDURE DURING THE IMAGEN A METAL ARTIFACT WAS OBSERVED ON THE SPECIMEN FILM. IT COULD NOT BE CONFIRMED THE ORIGIN OF THE ARTIFACT OBSERVED. MULTIPLE ATTEMPTS TO THE CUSTOMER WERE UNSUCCESSFUL TO TRY TO OBTAIN IMAGES OR THE MATERIAL REPORTED. NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052085 ↗
• InjuryOct 20, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN EVIVA PROCEDURE, THE NEEDLE FAILED WHILE INSIDE THE BREAST. THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. THE DEVICE WAS REPORTED AS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980997 ↗
• MalfunctionJan 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON DECEMBER 23RD, AN EVIVA PROCEDURE WAS PERFORMED AND AS THE RADIOLOGIST REMOVED THE NEEDLE, THE CLIP INTRODUCER BROKE AND CAME APART, THE CLEAR SLEEVE CAME OUT WITH THE NEEDLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195160 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AN EVIVA PROCEDURE WAS PERFORMED AND THE SAMPLES TAKEN DID NOT CONTAIN ANY MICROCALCIFICATIONS. A TOTAL OF 24 SAMPLES WERE TAKEN BECAUSE AFTER 12 SAMPLES WERE TAKEN, THERE WAS NO LIME IN THE SAMPLES. THE NEEDLE TEST BEFORE THE BIOPSY SHOWED NO PROBLEMS. THE ATEC CONSOLE WAS CHECKED BY THE TECHNICIAN AND THERE IS NO PROBLEM THERE. ON (B)(6) INFORMATION RECEIVED THAT THE SECOND BIOPSY WAS COMPLETELY NEW WITH NEW PUNCTURE SITE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677383 ↗
• MalfunctionJun 21, 2021Suction Problem; Suction Problem

  ADDITIONAL INFORMATION ON THE PATIENT IMPACT WAS RECEIVED ON 06/29/2021. THE CUSTOMER REPORTED THAT THE BLEEDING WAS MENTIONED BECAUSE IT "CONTRIBUTED TO THE COMPLEXITY OF THE CASE." THE PATIENT WAS NOT ON ANY MEDICATION, SUCH AS BLOOD THINNERS, THAT COULD AFFECT BLOOD FLUIDITY. IT WAS KNOWN BEFORE THE PROCEDURE THAT THE PATIENT IS A "FAINTER" AND NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE REPORTED ISSUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope/Fainting

  MAUDE report 12034522 ↗
• MalfunctionMay 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE WHEN REMOVING THE PROBE TO INSERT THE SITE MARKER IT WAS DIFFICULT TO REMOVE. THE PROBE AND INTRODUCER HAD TO BE REMOVED TOGETHER AND A SITE MARKER WAS NOT ABLE TO BE PLACED. ONCE REMOVED IT WAS NOTED THE PROBE HAD BEEN BENT. THE PATIENT EXPERIENCED PAIN DURING REMOVAL, BUT NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 11838588 ↗
• MalfunctionApr 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHEN TRYING TO REMOVE THE NEEDLE TO PUT IN THE CLIP THE INTRODUCER SEEMED TO BE STUCK TO THE NEEDLE AND THE PATIENT. WHEN THE INTRODUCER WAS REMOVED IT WAS NOTED TO BE "SCRUNCHED UP." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715946 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS THE SECOND OF TWO REPORTS RELATED TO ONE EVENT. THE SECOND REPORT IS FILED UNDER 1222780-2020-00142. IT WAS REPORTED THAT DURING THE BIOPSY, AIR WAS PUSHED INTO THE BREAST AND IT TRAVELED UP TOWARD THE PATIENT NECK. THE PROCEDURE WAS ABORTED. AN X-RAY WAS PERFORMED BUT CAME BACK UNREMARKABLE. THE BIOPSY WAS NOT COMPLETED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10744447 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE BIOPSY WAS DONE AND AS THE TUBING WAS MOVED, "THE SPECIMEN CONTAINER OPENED FREELY (AS IF IT HAD NOT BEEN RE-CLOSED / LOCKED) AND OF COURSE ANY REMAINING FLUID - SALINE & BLOOD WAS SPILLED TO CLOTHING, FLOOR, VACUUM EQUIPMENT. THIS IS THE 3RD TIME IT HAS HAPPENED WITH THE PETITE NEEDLE." NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9573099 ↗
• MalfunctionNov 11, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE APERTURE WOULD NOT CLOSE DURING BIOPSY MODE. THE TISSUE THAT WAS OBTAINED WAS "TOO LITTLE AND TOO THIN." THE PROCEDURE WAS COMPLETED WITH THE LITTLE OBTAINED TISSUE. THE HANDPIECE SEEMS TO HAVE "LOW POWER SUCTION" AS COMMENTED BY RADIOLOGIST. RADIOLOGIST HAD TO TAKE THE NEEDLE OUT OF THE PATIENT BREAST WHILE THE APERTURE STILL OPEN. A SECOND DEVICE WAS NOT USED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307319 ↗
• MalfunctionOct 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE BIOPSY, THE BREAST TISSUE WAS DENSE AND THE CALCIFICATIONS MOVED AWAY FROM THE INCOMING NEEDLE. AS A RESULT THE DOCTOR DECIDED TO RETARGET AND WAS ABLE TO FIRE THE DEVICE THREE TIMES. AFTER SAMPLING AND LAVAGE, IT WAS DIFFICULT TO REMOVE THE NEEDLE FROM THE PATIENT BREAST. ULTIMATELY, THE DEVICE WAS REMOVED AND THE MARKER WAS THEN INSERTED. MARKER INSERTION WAS "NOT AS EASY AS USUAL," BUT THE MARKER PLACEMENT WAS SUCCESSFUL AND ACCURATE. REMOVING THE NEEDLE INTRODUCER SHEETH WAS DIFFICULT AND LOOKED "KNURLED" WHEN THE DEVICE WAS REMOVED FROM THE BREAST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166560 ↗