Sertera Biopsy Device Sertera-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045504059), received between Feb 17, 2023 and Feb 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

3 other recalls 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON JANUARY 25TH, A SERTERA PROCEDURE WAS PERFORMED AND THE NEEDLE DISLODGED WHILE RADIOLOGIST PERFORMED A TEST FIRE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400831 ↗
• MalfunctionFeb 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON JANUARY 25TH, A SERTERA PROCEDURE WAS PERFORMED AND UPON FIRING, TROUGH DISLODGED FROM THE DEVICE INTO THE PATIENT. WHEN PULLING THE DEVICE OUT THE TROUGH REMAINED IN THE PATIENT. HAD TO BE REMOVED MANUALLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397624 ↗

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-1170-2025 · Jan 15, 2025 · Open, Classified
  Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
• Z-2035-2023 · May 2, 2023 · Open, Classified
  Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
• Z-2869-2016 · Aug 22, 2016 · Terminated
  Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.