EVIVA 0913-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045505322), received between Dec 28, 2017 and Jun 25, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Failure to Fire; Failure to Fire

  IT IS REPORTED THAT ON (B)(6) 2025, DURING AN EVIVA PROCEDURE, THE USER REPORTED THE EVIVA PETITE BLUNT BIOPSY NEEDLE WOULD NOT FIRE. THE USER WAS GUIDED BY HOLOGIC TECHNICAL SUPPORT ON HOW TO INSTALL THE EVIVA PETITE BLUNT BIOPSY NEEDLE ONTO THE SYSTEM. ADDITIONALLY, IT IS REPORTED THAT THE USER WAS NOT UTILIZING THE STYLET HOLDER TO HOLD THE STYLET IN PLACE DURING THE INITIAL BIOPSY ATTEMPT. IT IS REPORTED THAT THE USER WAS ABLE TO UTILIZE THE STYLET HOLDER AND COMPLETE A SUCCESSFUL BIOPSY; HOWEVER, THE PATIENT REQUIRED A SECOND INCISION TO DO SO. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329253 ↗
• InjuryApr 30, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING AN EVIVA PROCEDURE, THE PHYSICIAN EXPERIENCED ISSUES WITH THE SUCTION AND VACUUM. THE NEEDLE STOPPED WORKING AFTER COLLECTING THE SAMPLES AND THE VACUUM ERROR WAS DISPLAYED. AT THIS POINT THE NEEDLE WAS EXCHANGED TO COMPLETED THE PROCEDURE BUT ANOTHER INCISION HAD TO BE PERFORMED. PATIENT WAS UNDER COMPRESSION FOR A LONG TIME AND PRESENTED WITH A BREAST HEMATOMA. UNKNOWN MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE HEMATOMA AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 21936766 ↗
• MalfunctionSep 26, 2018Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A PLASTIC INTRODUCER SHEETH OF THE DEVICE WAS SHREDDED. AS INDICATED, THE DEVICE TEST AND THE BIOPSY PROCEDURE WERE ALL SUCCESSFULLY PERFORMED. HOWEVER, WHEN THE PHYSICIAN WANTED TO REMOVE THE BIOPSY DEVICE AT THE END OF THE PROCEDURE, SHE FELT RESISTANCE. THEN BY PULLING IT OUT WITH POWER, THE PLASTIC INTRODUCER SHEETH WAS DAMAGED AND BROKEN AT ITS END. AS REPORTED, NO PATIENT HARM, INJURY OR IMPACT DID OCCUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910206 ↗
• MalfunctionSep 11, 2018Defective Component

  THE HOLOGIC BIOPSY PROBE, EVIVA STANDARD 9G DID NOT FUNCTION WHEN WE HAD THE PATIENT IN POSITION PRONE ON THE TABLE READY FOR BIOPSY. WE HAD TO DELAY THE START OF THE BIOPSY WHILE WE EXCHANGED THE DEFECTIVE PROBE FOR ONE THAT WORKED PROPERLY. THIS EXTENDED THE LENGTH OF TIME THE PATIENT WAS PRONE AND COMPRESSION.

  Patient problems: No Information

  MAUDE report 7863664 ↗
• MalfunctionDec 28, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PHYSICIAN COMPLETED AN EVIVA BREAST BIOPSY ON (B)(6) 2017 AND HAD DIFFICULTY REMOVING THE DEVICE. WHEN THE PLASTIC INTRODUCER SHEATH WAS REMOVED THERE WERE SOME MISSING PLASTIC PARTS. THE PHYSICIAN THEN NOTED THE PLASTIC PARTS WERE LOCATED AT THE PATIENT'S INCISION HOLE. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7152413 ↗