EleVation™ EVDRIVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741182365), received between Mar 7, 2023 and Dec 4, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT DURING COMPLAINT INVESTIGATION, ADDITIONAL FAILURE WAS IDENTIFIED THAT WAS A NON-CASCADING EVENT, THAT WERE NOT REPORTED INITIALLY BY THE FACILITY BUT WERE FOUND DURING THE SERVICE CENTER EVALUATIONS AND CONFIRMED BY THE COMPLAINT INVESTIGATION TEAM. THIS NON-CASCADING EVENT WAS IDENTIFIED WITH THE ELEVATION DRIVER'S BOTTOM LABEL IS RUBBED AWAY/ SMEARED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712736 ↗
• MalfunctionDec 2, 2025Missing Information; Missing Information

  IT WAS REPORTED THAT DEVICE REQUIRES PREVENTATIVE MAINTENANCE. THERE ARE NO REPORTED DEVICE MALFUNCTIONS. ADDITIONAL INFORMATION, DURING EVALUATION AT THE SERVICE DEPOT, THE ELEVATION DRIVER A BROKEN RESET SWITCH, INTERMITTENTLY CALIBRATED AND WOULD FAIL THE PRIME/PIERCE TEST, FAILED THE VACUUM TEST, BATTERY SLIGHTLY PILLOWED, AND THE BOTTOM LABEL IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690947 ↗
• MalfunctionDec 2, 2025Missing Information; Missing Information

  IT WAS REPORTED THAT DEVICE REQUIRES PREVENTATIVE MAINTENANCE. THERE ARE NO REPORTED DEVICE MALFUNCTIONS. ADDITIONAL INFORMATION WAS PROVIDED BY THE SERVICE CENTER, THAT THE ELEVATION DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE DAMAGED. THERE IS A SUBSTANCE IN THE SEFAR NITEX FILTER, THE LEFT SCREW HOLE MOLDING ON THE BACK LID IS DENTED, THE CHARGING COIL IS DENTED ON THE LEFT SIDE, AND THE SERVICE CENTER CONFIRMED THAT THE BD SERIAL NUMBER LABEL WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690566 ↗
• MalfunctionDec 2, 2025Illegible Information; Illegible Information

  A PATIENT WAS PREPARED UNDERWENT FOR A BIOPSY PROCEDURE USING THE ELEVATION DRIVER. PRIOR TO THE PROCEDURE IT WAS REPORTED THAT THE DRIVER HAD AN ILLEGIBLE LABEL THAT WAS IDENTIFIED AT THE SERVICE CENTER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689984 ↗
• MalfunctionDec 1, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT ELEVATION DRIVER INITIATED A CALIBRATION BY ITSELF AND WILL NOT RESPOND TO ANY ATTEMPT TO PERFORM A SAMPLE OR PRIME FUNCTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677736 ↗
• MalfunctionSep 11, 2025Break; Contamination; Nonstandard Device; Suction Problem; Ambient Temperature Problem; Application Program Problem; Material Twisted/Bent; Missing Information; Break; Contamination; Nonstandard Device; Suction Problem; Ambient Temperature Problem; Application Program Problem; Material Twisted/Bent; Missing Information

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING EV DRIVER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ELEVATION DEVICE ALLEGEDLY HAD VACUUM SEAL PUNCTURED. IT WAS FURTHER REPORTED THAT THE LABEL WAS ALLEGEDLY REMOVED AND MISSING FROM THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023378 ↗
• MalfunctionAug 22, 2025Suction Problem; Failure to Obtain Sample; Illegible Information; Suction Problem; Failure to Obtain Sample; Illegible Information

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ELEVATION DRIVER. DURING PROCEDURE IT WAS REPORTED THAT THE, GEARS ARE GRINDING AND THE DEVICE WAS NOT CUTTING SMOOTHLY. ADDITIONALLY, INFORMATION WAS PROVIDED BY THE SERVICE CENTER THAT THE ELEVATION DEVICE HAS AN ILLEGIBLE LABEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870247 ↗
• MalfunctionJul 4, 2025Failure to Calibrate; Illegible Information; Failure to Calibrate; Illegible Information

  IT WAS REPORTED THAT THE EVDRIVER DEVICE WAS ATTEMPTED TO USE ON PATIENT BUT DID NOT START WORKING. THE PATIENT WAS NOT HURT IN ANY WAY. ONE ELEVATION 12G NEEDLE WAS ATTEMPTED TO BE USED. THE PROBLEM OCCURRED AS WE WERE TRYING TO TAKE OUR FIRST SAMPLE WITH THE NEEDLE IN THE PATIENT. ULTRASOUND PROCEDURE NORMAL DENSITY BREAST WE COMPLETED THE PROCEDURE BY USING A BARD MARQUEE 12G NEEDLE THERE WAS NO DIFFICULTY ATTACHING THE NEEDLE TO THE DRIVER. SAMPLE BUTTON PRESSED TO MAKE SURE IT WAS CONNECTED CORRECTLY, AND IT WAS. THEN WENT TO USE THE DEVICE DURING THE ACTUAL BIOPSY AND WHEN THE SAMPLE BUTTON WAS PRESSED NOTHING HAPPENED. THE DRIVER WAS NOT WORKING AT ALL. AFTER WE COMPLETED THE BIOPSY AND DISMISSED THE PATIENT I DETACHED AND REATTACHED THE DRIVER TO THE NEEDLE, AND IT STILL WOULD NOT DO ANYTHING. ADDITIONAL INFORMATION WAS PROVIDED WHEN THE DEVICE ARRIVED AT THE SERVICE CENTER, THE ELEVATION DRIVER DEVICE HAS AN ILLEGIBLE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403146 ↗
• MalfunctionJul 3, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE ELEVATION DEVICE STICKER IS ILLEGIBLE AS THE STICKER HAS WORN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395472 ↗
• MalfunctionApr 14, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT DEVICE IS COMING IN ON AN EXPIRED RENTAL CONTRACT. THERE WERE NO ALLEGED DEFICIENCIES REPORTED. ADDITIONAL INFORMATION RECEIVED, WHEN THE DEVICE ARRIVED AT THE SERVICE CENTER THE LABEL ON DEVICE WAS ILLEGIBLE AND NO SAFETY OR SERIAL NUMBER COULD BE SEEN. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832323 ↗
• MalfunctionMar 5, 2025Break; Contamination; Corroded; Suction Problem; Device Markings/Labelling Problem; Moisture or Humidity Problem; Break; Contamination; Corroded; Suction Problem; Device Markings/Labelling Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A SUCTION ISSUE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21522726 ↗
• MalfunctionOct 21, 2024Contamination; Suction Problem; Moisture or Humidity Problem; Illegible Information; Contamination; Suction Problem; Moisture or Humidity Problem; Illegible Information

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, IT WAS NOTED THAT THE DEVICE LABEL IS ALLEGEDLY BLANK. FURTHERMORE, THERE IS NO LONGER ANY PRINTED INFORMATION ON THE LABEL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492272 ↗
• MalfunctionSep 16, 2024Failure to Charge; Device-Device Incompatibility; Illegible Information; Failure to Charge; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE PROBE WAS NOT ALLEGEDLY ABLE TO FLUSH ONTO THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225124 ↗
• MalfunctionAug 7, 2024Failure to Charge; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Illegible Information; Failure to Charge; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PROBE ALLEGEDLY GOT STUCK IN THE DRIVER DUE TO A BENT LOCKING BRIDGE. IT WAS FURTHER REPORTED THAT THE DEVICE'S SERIAL NUMBER AND SAFETY INSTRUCTIONS ON THE LABEL WAS ALLEGEDLY ILLEGIBLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935395 ↗
• MalfunctionAug 7, 2024Failure to Obtain Sample; Illegible Information; Failure to Obtain Sample; Illegible Information

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY NOT MOVING THE SAMPLES FROM THE DEVICE INTO THE SAMPLE CUP DUE TO THE VACUUM BEING COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19926972 ↗
• MalfunctionMar 7, 2023Contamination; Failure to Prime; Self-Activation or Keying; Failure to Calibrate; Failure to Fire; Contamination; Failure to Prime; Self-Activation or Keying; Failure to Calibrate; Failure to Fire

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO CALIBRATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495822 ↗