EleVation™ EV10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741182372), received between Nov 26, 2022 and Jul 29, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ELEVATION INSTRUMENT. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS A PIECE OF METAL MIXED IN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641581 ↗
• InjuryNov 5, 2024Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED VACUUM ASSISTED BREAST BIOPSY THROUGH HARD DENSITY TISSUE, THREE RED LIGHTS ALLEGEDLY CAME ON THE SAMPLE LIGHT, THE OPTIONAL TRIGGER LIGHT AND THE INTELLIGENT MODE LIGHTS WHILE PRESSING SAMPLE BUTTON. IT WAS FURTHER REPORTED THAT THERE WAS BLEEDING, RESULTING IN A HEMATOMA. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS STABLE NOW.

  Patient problems: Hematoma

  MAUDE report 20608044 ↗
• MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THE CONNECTION OF THE SUPPORT CANNULA WAS ALLEGEDLY DISLODGED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708632 ↗
• MalfunctionNov 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE DEVICE, A FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866803 ↗