EVIVA_0910-12TRecalls & reported problems
Hologic, Inc. · PRODUCT, EVIVA, TROCAR, 9 GA, 10 CM LENGTH, 12MM APERTURE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045504943), received between Nov 10, 2025 and Apr 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026
FROM STAFF: BIOPSY NEEDLE DID NOT PASS TEST RUN WHEN ATTACHED CORRECTLY. WOULD NOT "FIRE". NEEDLE INFO: EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM BIOPSY DEVICE: PETITE SIZE, LOT E25J29RJ, EXP 9/29/2027.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895095 ↗MalfunctionFeb 9, 2026
FROM STAFF: THE STEREOTACTIC BREAST BIOPSY DEVICE DID NOT PASS THE INITIAL SET-UP CHECK. AFTER THE BREAST BIOPSY DEVICE WAS ATTACHED TO BIOPSY MACHINE AND SET-UP AS STATED BY MANUFACTURE GUIDELINES A TEST FIRE WAS DONE. THE BIOPSY DEVICE DID NOT PASS TEST FIRE STAGE. THIS DEVICE WAS REMOVED FROM THE AREA, AND A NEW BIOPSY DEVICE WAS OPENED. THE BIOPSY DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. EVIVA STEREOTACTIC GUIDED BREAST BIOPSY PETITE SYSTEM. LOT-E25G02RJ, EXP 2027-07-02.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290722 ↗MalfunctionNov 10, 2025Failure to Fire
NEEDLE DID NOT TEST APPROPRIATELY--DID NOT MAKE SOUND ON TEST FIRE. PATIENT ON TABLE PREPARED FOR STEREOTACTIC BIOPSY. FAULTY NEEDLE--TEST DID NOT WORK PROPERLY. CONTINUE TO ALWAYS TEST THE NEEDLE BEFORE USING ON PATIENT, NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509332 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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