EleVationRecalls & reported problems across all models

We found 4 models of EleVation by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2021 and Dec 4, 2025 — classified as 5 injuries, 39 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EleVation problems

EleVation models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EleVation™ EV14

  INSTRUMENT, BIOPSY
  17 reports
• EleVation™ EVDRIVER

  INSTRUMENT, BIOPSY
  16 reports
• EleVation™ EV12

  INSTRUMENT, BIOPSY
  7 reports
• EleVation™ EV10

  INSTRUMENT, BIOPSY
  4 reports

Recent EleVation adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionOct 21, 2025Component Incompatible; Detachment of Device or Device Component; Component Incompatible; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A VACUUM ASSISTED BREAST BIOPSY PROCEDURE USING THE ELEVATION PROBE. PRIOR TO THE PROCEDURE, THE OUTER GUIDING TUBE WAS FOUND DETACHED UPON OPENING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346229 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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