Mammotome MAMMOMARK 2 MAM3008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911101659), received between Feb 6, 2020 and Nov 2, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE REPRESENTATIVE THAT DOCTOR CALLED AND STATED THAT WHEN HE DEPLOYED MAM3008 HE HAD A HARD TIME PULLING THE APPLICATOR OUT. WHEN HE DID PULL IT OUT IT LOOKED LIKE THE TIP WAS MISSING AND THERE WAS A PIECE OF COLLAGEN STUCK ON THE END. THEY X-RAY'D THE PATIENT AND IT LOOKS LIKE THE TIP IS INSIDE THE BREAST. THE REPRESENTATVIE LET THEM KNOW THAT IT APPEARS TO BE TIP SHEER. THE REPRESENTATIVE WILL REACH OUT TO THE DOCTOR TO FACILITY TO TRAIN ON HOW TO USE MAM3008. THIS INCIDENT IS RECORDED AS COMPLAINT NUMBER (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15716214 ↗
• InjuryJan 7, 2022Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A MARKER WAS DEPLOYED INTO THE PATIENT BUT IT DID NOT SHOW UP IN POST IMAGES SO THEY DEPLOYED A SECOND MARKER. THE SECOND MARKER WAS SUCCESSFULLY DEPLOYED BUT WHEN THE DOCTOR TRIED TO PULL THE PRODUCT OUT FROM THE BREAST THERE WAS RESISTANCE. AFTER THE PROCEDURE THEY COULD CONFIRM THAT THE DISTAL TIP OF THE APPLICATOR WAS STILL IN THE BREAST. THE DOCTOR IS REQUESTING INFORMATION TO SEE IF THE APPLICATOR TIP NEEDS TO BE REMOVED. THEY ARE WAITING ON THE RESULTS OF THE BIOPSY TO SEE IF THE PATIENT NEEDS A LUMPECTOMY AND THAT THEY COULD REMOVE THE APPLICATOR TIP AT THAT TIME AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13197598 ↗
• MalfunctionFeb 6, 2020Mechanical Problem; Mechanical Problem

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT BY SALES REPRESENTATIVE OF A MAM3008 TIP SHEAR DURING A PROCEDURE. TIP OF DEPLOYMENT DEVICE CUT OFF IN PATIENT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9679771 ↗