Mammotome MAMMOMARK MAM3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841911101598), received between Nov 9, 2018 and Apr 11, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING THE DEVICE PLACEMENT, DEVICE BROKE OFF AND WAS LEFT IN SAME AREA AS MARKER, THIS NEEDED TO BE REMOVED SURGICALLY DURING MASS REMOVAL. SAMPLE AREA WITH BREAST MARKER WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 14079745 ↗
• InjuryApr 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE THAT WHILE DOCTOR WAS INSERTING THE MARKER CLIP, THE SHEATH SHEARED AND WHEN SURGEON TOOK OUT SHEATH, A PIECE WAS LEFT INSIDE. FOREIGN BODY WAS ABLE TO BE SEEN BY MAMMOGRAM. PATIENT TRANSFERRED TO ROOM FOR REMOVAL OF FOREIGN BODY WITH FLURO.

  Patient problems: Foreign Body In Patient

  MAUDE report 14079703 ↗
• MalfunctionDec 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ULTRASOUND PROCEDURE THEY HAD AN ISSUE WHERE THE MARKER WOULD NOT RELEASE FROM THE PLUNGER SO HE ROTATED IT AND IT RELEASED HOWEVER HE THEN TRIED TO REMOVE THE MARKER INTRODUCER AND IT BECAME "STUCK" . HE PUSHED FORWARD AND IT SEEMED TO RELEASE AND HE REMOVED THE MARKER. THE DOCTOR KEPT THE PLUNGER DEPRESSED WHILE HE PULLED BACK ON THE MARKER MOST LIKELY. UPON FOLLOW UP THEY SAY THE TIP SHEAR NEXT TO THE CLIP. THIS EVENT IS DOCUMENTED IN OUR SYSTEM AS COMPLAINT#(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10982885 ↗
• InjuryAug 2, 2019Device Damaged by Another Device; Device Damaged by Another Device

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM USER FACILITY, STATING, TIP SHEAR OCCURRED DURING STEREO BIOPSY. DOCTOR LEFT IN THE BREAST BECAUSE THEY ARE WAITING TO SEE IF PATIENT WILL GO TO SURGERY ONCE PATHOLOGY REPORT COMES BACK. DOCTOR PULLED MARKER OUT OF THE PROBE INSTEAD OF REMOVING THE PROBE/MARKER AS ONE UNIT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8854930 ↗
• InjuryNov 9, 2018Device Damaged by Another Device; Device Damaged by Another Device

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM THE AFFILIATE STATING, "DURING THE PROCEDURE, CONFIRMED THAT THE TIP OF THE INSERTER WAS LEFT IN BREAST FROM THE MAMMO MARK 11 REF# MAM3001 11G MARKER". THE TIP HAS NOT YET BEEN REMOVED FROM THE PATIENT. THIS PATIENT WILL BE SCHEDULED FOR A MORE EXTENSIVE SURGERY IN THE FUTURE. AS OF OCTOBER 26, THE PATIENT HAD NOT EXPERIENCED ANY COMPLICATIONS. THIS HAS BEEN DOCUMENTED AS REPORT # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8055703 ↗