CELERO-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15420045504929), received between Aug 29, 2019 and Sep 22, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859980 ↗
• InjurySep 21, 2026Failure to Obtain Sample

  It was reported by the user site that during a biopsy procedure utilizing the device, the user was "Obtaining core samples from patient during biopsy procedure. On the third pass the device would not engage, unable to open and retrieve core sample. Attempted multiple times to engage device to no effect. Had to utilize another." As a result of the reported device malfunction, tissue could not be obtained with the initial device. The procedure was completed using another device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839231 ↗
• InjuryDec 16, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED BY THE USER SITE THAT DURING A CELERO BIOPSY PROCEDURE ON (B)(6) 2025, "SPECIMEN WAS OBTAINED USING THE PRE-FIRE METHOD. HOWEVER, THE BIOPSY NEEDLE WOULD NOT REOPEN TO RETRIEVE THE SPECIMEN. THE HAND "PRIMING" FUNCTION HAD ZERO RESISTANCE AND DID NOT APPEAR TO BE WORKING PROPERLY, SO THE 1 AND 2 BUTTONS DID NOT RESPOND WHEN PUSHED. THE BIOPSY SEQUENCE WAS ATTEMPTED AT LEAST 15 TIMES, WITHOUT SUCCESS. THE PATIENT DEVELOPED A HEMATOMA AFTER THE SECOND PASS AND THE AREA WAS NO LONGER VISUALIZED, SO THE PROCEDURE WAS ABORTED. THE PATHOLOGY RESULTS WERE DISCORDANT, REQUIRING A SECOND BIOPSY SEVERAL WEEKS LATER." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 23817055 ↗
• InjuryOct 21, 2025Failure to Obtain Sample; Material Twisted/Bent; Failure to Obtain Sample; Material Twisted/Bent

  IT WAS REPORTED BY THE USER THAT DURING A CELERO PROCEDURE ON (B)(6) 2025, TISSUE SAMPLES WERE DIFFICULT TO ACQUIRE, AND THE NEEDLE BENT WHEN IT PENETRATED "HARD TISSUE." IT IS REPORTED THAT THE NEEDLE WAS WITHDRAWN FROM THE PATIENT'S BREAST AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; HOWEVER, AN X-RAY WAS OBTAINED TO ENSURE NO METAL FRAGMENTS REMAINED INSIDE THE PATIENT. IT IS REPORTED THAT NO FOREIGN MATERIAL WAS OBSERVED INSIDE OF THE PATIENT AND THE PATIENT EXPERIENCED NO ADVERSE HEALTH EFFECTS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350244 ↗
• MalfunctionMay 5, 2025Difficult to Open or Close

  RADIOLOGIST WAS PERFORMING A BREAST BIOPSY ON THE PATIENT. HE WAS ABLE TO OBTAIN 2 ADEQUATE SAMPLES. AFTER RETRIEVING THE 2ND SAMPLE FROM THE DEVICE, THE DEVICE HANDLE WOULD NOT CLOSE AND SET TO RETRIEVE ADDITIONAL SAMPLES. ANOTHER DEVICE WAS OPENED AND THE BIOPSY CONTINUED.

  Patient problems: Insufficient Information

  MAUDE report 21960736 ↗
• MalfunctionSep 6, 2024

  THE PATIENT WAS HERE FOR A BREAST BIOPSY. PRIOR TO STARTING THE PROCEDURE, THE RADIOLOGIST CHECKED THE CELERO DEVICE BY PUMPING THE HANDLE AND PRE-FIRING THE DEVICE. THE HANDLE WOULD PUMP, BUT THE DEVICE WOULD NOT PREFIRE. THE DEVICE DID NOT GO INTO THE PATIENT'S BREAST. ANOTHER DEVICE WAS OPENED, CHECKED, AND THE PROCEDURE STARTED AND WAS COMPLETED SUCCESSFULLY WITH THE SECOND CELERO DEVICE. DEVICE INFO: CELERO BREAST BIOPSY DEVICE. REF: CELERO-12. LOT: E23E05RP. EXP: 5/4/2025. BAR CODE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155516 ↗
• MalfunctionAug 15, 2024

  PATIENT WAS HERE FOR A BREAST BIOPSY. RADIOLOGIST HAD ONE SUCCESSFUL PASS. THE DEVICE WAS PRE-FIRED, PLACED INTO THE PATIENT'S BREAST, AND THE DEVICE FAILED TO CAPTURE THE SPECIMEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE RADIOLOGIST TRIED TO PRESS THE CAPTURE BUTTON, BUT IT WOULD NOT BUDGE. THEREFORE, A SECOND DEVICE WAS OPENED AND WE SUCCESSFULLY PRECEDED WITH THE BIOPSY. DEVICE INFO: CELERO BREAST BIOPSY DEVICE 12 GAUGE. REF: CELERO-12, LOT# E23E05RP, EXP 5/4/25. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990346 ↗
• MalfunctionAug 6, 2024

  PATIENT WAS HERE FOR A LEFT BREAST BIOPSY. RADIOLOGIST WAS ABLE TO OBTAIN TWO ADEQUATE TISSUE SAMPLES. HOWEVER, AFTER TAKING THE SECOND SAMPLE OUT OF THE DEVICE'S SAMPLING NOTCH, THE DEVICE WOULD NOT ALLOW TO BE RESET FOR ANOTHER SAMPLE. THEREFORE, ANOTHER DEVICE WAS OPENED, AND THE BIOPSY WAS THEN COMPLETED. DEVICE INFO: CELERO BREAST BIOPSY DEVICE BY HOLOGIC, INC. (12 GAUGE). LOT: E23E05RP. EXP: 5/4/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917067 ↗
• InjuryJan 9, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A CELERO PROCEDURE ON (B)(6) 2023, THE THROUGH WAS NOT WORKING CORRECTLY AND THE NEEDLE WAS PLACED INSIDE THE BREAST BUT COULD NOT RETRIEVE A BIOPSY. THE BIOPSY COULD NOT BE RETRIEVED, AND THE PROCEDURE WAS ABORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479700 ↗
• MalfunctionAug 29, 2019Activation Failure

  THE DEVICE DID NOT DEPLOY. NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8944406 ↗