Mammotome revolve MST1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841911100744), received between Jul 18, 2018 and Apr 15, 2020 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY SALES REP THAT AFTER SUCCESSFUL BIOPSY WITH ST MODALITY THERE WERE CURLY, STRING LIKE, OPAQUE, TINY, SHORT, THREADLIKE ARTIFACTS SEEN IN THE SPECIMEN FILM. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4). DEVICOR COULD NOT CONCLUDE THAT OUR DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT, DUE TO THE ALLEGATION OF AN ARTIFACT SEEN ON THE SPECIMEN FILM THIS HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803. AS SUCH, WE ARE SUBMITTING THIS MEDWATCH REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9965875 ↗
• MalfunctionOct 4, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(6) STATING THAT "TISSUE SAMPLES BYPASSED THE COLLECTION CUP AND WENT STRAIGHT INTO THE CANISTER. AFTER THE PROCEDURE, WHEN THEY CHECKED THE CANISTER, THERE WAS A LOT OF ADIPOSE TISSUES. ALSO THEY FOUND A CALCIFIED TISSUE IN IT. NO PATIENT COMPLICATIONS." THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9159416 ↗
• MalfunctionJul 2, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, DURING THE PROCEDURE THE 10G PROBE DIDN'T GET ANY SAMPLES. NO PATIENT COMPLICATIONS. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS REPORT #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752599 ↗
• MalfunctionMay 24, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(4), STATING THE USER ACQUIRED 6 TISSUE SAMPLES, BUT THERE WERE ONLY 5 SAMPLES IN THE SMS (SAMPLE MANAGEMENT SYSTEM) AND THEN THEY FOUND A TISSUE SAMPLE IN THE CANISTER. THIS SAMPLE HAS MANY CALCIFICATIONS AND THE USER BELIEVES THAT IT IS FIRST SAMPLE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641263 ↗
• MalfunctionMay 22, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, THE ELITE WOULD NOT SUCTION PER THE NURSE BUT THEN STARTED MAKING A HISSING NOISE AND IT GOT CLOGGED. SAMPLE WAS NOT ADEQUATE, BUT SENT TO PATHOLOGY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634166 ↗
• InjurySep 9, 2018Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED BY THE SALES PERSON THAT THE PROBE DOES NOT PHYSICALLY PRESENT ANY DEFECT, BUT WHEN CONNECTING IT TO THE HOLSTER THE PROBE PRODUCES A VACUUM ERROR AND WILL NOT PRODUCE A VACUUM. THE VACUUM ERROR IS PRESENTED RANDOMLY. PROCEDURE WAS COMPLETED WITH DEVICE. PATIENT HAD A HEMATOMA. SURGICAL STITCHES WERE APPLIED.

  Patient problems: Hematoma

  MAUDE report 7858654 ↗
• MalfunctionSep 6, 2018Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. HAS RECEIVED A REPORT FROM AFILIATE, DEVICOR MEDICAL (B)(4) STATING, "AFTER THE PROCEDURE THERE WERE TISSUE SAMPLES IN THE CANISTER, NOT TRAY. THE USER INVESTIGATED AND FOUND CALCIFIED SAMPLE. NO PATIENT COMPLICATIONS". THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850172 ↗
• MalfunctionJul 18, 2018Failure to Obtain Sample; Failure to Obtain Sample

  TROUBLESHOOTING IN VAB, NO CORE IN THE TRAY.

  Patient problems: Hematoma

  MAUDE report 7697707 ↗

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