Mammotome revolve MHUS08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841911100812), received between Dec 26, 2018 and Oct 2, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K152989); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL KOREA, STATING, "DURING A BREAST BIOPSY PROCEDURE 1. THE SAMPLES WERE STUCK IN THE NEED SHAFT AND DIDN'T COME OUT. 2. THE CUSTOMER COMPLETED THE PROCEDURE WITH ANOTHER NEW PROBE. NO PATIENT CONSEQUENCE." ON SEPTEMBER 10, 2019, MAMMOTOME BECAME AWARE THAT BREAST TISSUE WAS UNEXPECTEDLY FOUND IN THE DEVICE DURING THE FAILURE INVESTIGATION. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145810 ↗
• MalfunctionSep 29, 2019Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED BY AFFILIATE DURING PROCEDURE THE NEEDLE DID NOT TAKE THE SPECIMENS, THE PREPARATIONS WERE IN THE SUCTION TUBES AND IN THE NEEDLE PATH. AFTER REMOVING THE NEEDLE FROM THE BREAST, THE DOCTOR PUSHED THE PREPARATIONS THROUGH THE PLACE OF APPLICATION OF THE MARKER. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS. RECORD# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9132513 ↗
• MalfunctionJul 9, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE DEVICOR MEDICAL DEVICE (B)(4) CO. STATING, "DURING PROCEDURE INADEQUATE TISSUE OR NO TISSUE AND ERROR CODE 804/808 AFTER 1-5 CUTS". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772571 ↗
• MalfunctionMay 24, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(6), STATING "DURING THE PROCEDURE, ERROR MESSAGE OCCURRED AND INNER CUTTER OF THE PROBE STOPPED IN THE MIDDLE". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640017 ↗
• MalfunctionApr 16, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(4), STATING, DURING A BREAST BIOPSY PROCEDURE, AFTER 3-4 SAMPLES WERE TAKEN, A 603 ERROR MESSAGE OCCURRED AND ONE OF THE SAMPLE IS IN THE VACUUM TUBING LINE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518465 ↗
• MalfunctionMar 26, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM OUR (B)(6) AFFILIATE STATING, DURING A BREAST BIOPSY PROCEDURE, THE SAMPLES WERE STUCK IN THE VACUUM LINE WHERE THEY ARE NOT SUPPOSED TO ENTER. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451170 ↗
• InjuryDec 26, 2018Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM THE AFFILIATE STATING, " IN THE SAMPLE MODE, BREAST TISSUE COULD NOT BE TAKEN. USER PRESSED THE SAMPLE BUTTON; BREAST TISSUE COULD NOT BE TAKEN AND THE SUCTION FUNCTION WAS ACTIVATED AND 3-WAY VALVE OPENED AND SALINE WAS INJECTED WITH A SYRINGE BUT BREAST TISSUE SAMPLE NOT HELD IN CHAMBER. PROCEDURE WAS COMPLETED WITH ANOTHER PROBE WITH NO PATIENT CONSEQUENCE". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152989. One submission often covers many models, so check the product and lot details in each record.

• Z-1512-2017 · Feb 28, 2017 · Terminated
  Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance