Sertera Biopsy Device Sertera-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15420045504066), received between Jan 14, 2022 and Sep 30, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K150169); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 15, 2025Open, Classified

   Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

   Z-1170-2025 · Root cause: Process control · FDA record ↗

2. May 2, 2023Open, Classified

   The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

   Z-2035-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Failure to Obtain Sample

  It was reported by the user site that during a breast biopsy procedure on (b)(6)2026, "The radiologist was doing an u/s "[ultrasound]" guided core biopsy and stated that he took 3 samples and all three samples came back "shredded". He then switched needles and the new needle samples were good." No patient and/or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942525 ↗
• InjuryJan 29, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A SERTERA PROCEDURE ON (B)(6) 2025, WHEN THE RADIOLOGIST TOOK THE SAMPLE THE DEVICE WAS STUCK AND WOULDN´T LET THEM UNSHEATHE TO GET THE CORE. THE CUSTOMER RESPONDED THAT THE TISSUE WAS LOST AND COULDN´T BE USED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261425 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6), A SERTERA PROCEDURE WAS PERFORMED AND WHEN THE RADIOLOGIST FIRED THE NEEDLE THE FIRST TIME OUTSIDE THE PATIENT NOTICED THE NEEDLE LOOKED TOO LONG AND FULLY FIRED SO THEY DECIDED TO COCKED IT AGAIN TO TEST IT. THIS TIME THE RADIOLOGIST NOTICED THE TROUGH SEEMED TO NOT BE FULLY RETRACTED IN THE NEEDLE WHEN COCKED. WHEN THE RADIOLOGIST FIRED THE NEEDLE CAME OUT AND HIT THE WALL AND BOUNCED OFF THE WALL AND HIT THE FLOOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372201 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SERTERA PROCEDURE ON MARCH 7TH, THE PHYSICIAN PRE-TESTED THE NEEDLE BEFORE USING IT ON THE PATIENT AND THE NEEDLE DISCONNECTED AND DISCHARGED WHILE IN THE PHYSICIAN´S HAND. NO PATIENT OR STAFF INJURY REPORTED. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611840 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON IT'S OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029249 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) "2022", A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON IT'S OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029051 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON IT'S OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028994 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON IT'S OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028975 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON IT'S OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028962 ↗
• MalfunctionDec 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE UNIT IS FIRING ON ITS OWN AFTER BEING TESTED AND WITHOUT BEING IN HANDS OF PHYSICIAN. THE DOCTOR DID NOT NOTICE ANY ISSUE UNTIL THE ISSUE OCCURRED DURING TESTING. THE INNER CANNULA DETACHED AFTER FIRING. THE DEVICE WAS COCKED FOR TESTING PURPOSES PRIOR TO USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992060 ↗
• MalfunctionNov 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SERTERA PROCEDURE WAS PERFORMED, AND THE DEVICE MADE A RATTLING NOISE. THE DEVICE WAS NOT ABLE TO GET A CORE WHEN INSERTED INTO THE PATIENT'S SKIN AND THEN A PIECE GOT DISLODGED AND DISCHARGED FROM THE DEVICE . THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889847 ↗
• MalfunctionNov 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A SERTERA PROCEDURE WAS PERFORMED, AND THE FIRST NEEDLE, THE ONE THAT THE DOCTOR PRE-FIRED GOT DISLODGED AND WAS DISCHARGED FROM THE HANDPIECE. NO HARM OR INJURY WAS REPORTED TO THE PATIENT OR USER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889734 ↗
• MalfunctionJan 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SERTERA BIOPSY PROCEDURE , TWO NEEDLES WERE USED INSIDE THE BREAST AND COULD NO COLLECT SAMPLES. THE PROCEDURE HAD TO BE ABORTED AND RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258689 ↗
• MalfunctionJan 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SERTERA BIOPSY PROCEDURE , TWO NEEDLES WERE USED INSIDE THE BREAST AND COULD NO COLLECT SAMPLES. THE PROCEDURE HAD TO BE ABORTED AND RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150169. One submission often covers many models, so check the product and lot details in each record.

• Z-2869-2016 · Aug 22, 2016 · Terminated
  Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.