EleVation™ EV14Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741182396), received between Jun 8, 2021 and Oct 21, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE BASE OF THE COAXIAL WAS ALLEGEDLY BROKEN WHEN TRIED TO CALIBRATE. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO USE THE PROBE AFTER INSTALLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557235 ↗
• MalfunctionJan 31, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE CARGO ALLEGEDLY ARRIVED UNWRAPPED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280786 ↗
• MalfunctionJan 31, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VACUUM-ASSISTED BREAST BIOPSY PROCEDURE, THE CARGO ALLEGEDLY ARRIVED UNWRAPPED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280785 ↗
• MalfunctionJul 21, 2023Failure to Obtain Sample; Device Contamination with Chemical or Other Material; Failure to Obtain Sample; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE SAMPLES ALLEGEDLY GOT STUCK IN THE PROBE NEAR THE SAMPLE CONTAINER, AND THE DEVICE ALLEGEDLY HAD A FILLING PROBLEM. IT WAS FURTHER REPORTED THAT THE SAMPLES COULD BE TAKEN OUT EVENTUALLY USING A THIN NEEDLE, BUT A TRANSPARENT FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THE POSSIBILITY THAT THIS MATERIAL IS A TUMOR CANNOT BE RULED OUT, AND THE PHYSICIAN HAS REQUESTED AN IN-HOSPITAL PATHOLOGICAL TEST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369804 ↗
• MalfunctionMay 31, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Suction Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Suction Problem

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY LACKED POWER FOR THE SECOND ASPIRATION. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY GOT STUCK INSIDE THE BREAST AND WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029617 ↗
• MalfunctionApr 28, 2023Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, WHILE REMOVING THE NEEDLE FROM THE COAXIAL WHICH IS LEAVED IN PLACE IN ORDER TO PLACE BREAST TISSUE MARKER, THE NEEDLE ALLEGEDLY DID NOT CAME FREE FROM THE COAXIAL. IT WAS FURTHER REPORTED THAT A FOREIGN OBJECT WAS NOTICED TO BE STUCK IN THE DISTAL END OF THE TIP OF THE CUTTER OF THE NEEDLE WHICH WOULD HAVE STOPPED IT FROM COMING THROUGH THE COAXIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829853 ↗
• MalfunctionMar 8, 2023Failure to Cycle; Difficult to Remove; Failure to Obtain Sample; Failure to Cycle; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH FATTY TISSUE, THE DEVICE ALLEGEDLY FAILED TO CYCLE. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE TISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501683 ↗
• MalfunctionDec 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, A FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED ON THE NEEDLE PROTECTOR UPON OPENING THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15922569 ↗
• MalfunctionJul 19, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE SAMPLE CONTAINER WAS ALLEGEDLY HARD TO OPEN. THE SAMPLES SPILLED OUT AS THE PHYSICIAN APPLIED STRONG FORCE TO OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050674 ↗
• InjurySep 27, 2021Failure to Cycle; Failure to Obtain Sample; Failure to Cycle; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. COAXIAL WAS USED. PATIENT EXPERIENCED BRUISED.

  Patient problems: Bruise/Contusion

  MAUDE report 12531251 ↗
• MalfunctionAug 10, 2021Filling Problem; Improper or Incorrect Procedure or Method; Failure to Obtain Sample; Filling Problem; Improper or Incorrect Procedure or Method; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILURE TO OBTAIN SAMPLE. A COAXIAL NEEDLE WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300778 ↗
• MalfunctionJun 8, 2021Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956659 ↗
• MalfunctionJun 8, 2021Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956658 ↗
• MalfunctionJun 8, 2021Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956656 ↗
• MalfunctionJun 8, 2021Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956655 ↗
• MalfunctionJun 8, 2021Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11955632 ↗