EleVation™ EV12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741182389), received between Mar 26, 2021 and Nov 3, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING ELEVATION PROBE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE OPENED, PULLED TISSUE IN, CLOSED, AND GOT STUCK WITH RED LIGHTS/BEEPING. THE SAMPLES WERE NOT ABLE TO BE RETRIEVED, AND THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447978 ↗
• MalfunctionMay 20, 2025Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A VACUUM ASSISTED ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE USING THE ELEVATION. FURTHER DURING THE PROCEDURE, SUCTION WAS NOT PERFORMED PROPERLY. UPON CHECKING, THE RUBBER PACKING HAD COME OFF, SO THE NEEDLE WAS CHANGED, AND SUCTION WAS PERFORMED AGAIN, AND SUCTION WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049832 ↗
• InjuryMay 16, 2025Suction Problem; Failure to Obtain Sample; Noise, Audible; Suction Problem; Failure to Obtain Sample; Noise, Audible

  IT WAS REPORTED THAT DURING A BIOPSY THROUGH HARD DENSITY TISSUE, THE DEVICE ALLEGEDLY HAD SUCTION PROBLEM. IT WAS FURTHER REPORTED THAT THE CANULA WAS NO LONGER SUCKING UP THE SAMPLES, AND NEITHER WAS THE HAEMATOMA, AS THE PROCEDURE WAS HAEMORRHAGIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22034287 ↗
• MalfunctionJan 15, 2024Failure to Cycle; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Failure to Cycle; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO CYCLE. IT WAS FURTHER REPORTED THAT THE DRIVER ALLEGEDLY TURNED RED ON THE LIGHTS AFTER BEING SMART MODE. IT WAS FURTHER REPORTED THAT THE PROBE WAS ALLEGEDLY TAKEN OUT OF THE PATIENT¿S BREAST DENSE TISSUE AND THE SAMPLE NOTCH WAS ALLEGEDLY EXPOSED CUTTING CANNULA OPEN. IT WAS FURTHER REPORTED THAT WHEN EXAMINING THE OPEN SAMPLE NOTCH, A SMALL METAL PIECE WAS ALLEGEDLY FOUND. IT APPEARED THAT THE METAL PIECE COULD HAVE BEEN A PRIOR TISSUE MARKER IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515292 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A HEMATOMA. HOWEVER, THE CAUSE OF THE HEMATOMA WAS NOT DUE TO A DEVICE MALFUNCTION. IT WAS FURTHER REPORTED THAT INITIALLY THE HEMATOMA WAS TREATED WITH A PRESSURE BANDAGE AND ICE. REPORTEDLY, THE PATIENT RETURNED TO THE SURGEON TO FURTHER TREAT THE HEMATOMA AND IT WAS SURGICALLY EXCISED. THE STATUS OF THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564542 ↗
• InjuryJan 10, 2023Suction Problem; Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem; Suction Problem; Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PAIN. REPORTEDLY, THE PATIENT WAS PROVIDED WITH PAIN MEDICATION FOR TREATMENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 16128623 ↗
• MalfunctionMar 26, 2021Difficult to Remove; Dull, Blunt; Material Twisted/Bent; Difficult to Remove; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY STUCK AND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573382 ↗