Mammotome revolve MST0812Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100720), received between Aug 6, 2018 and Jul 8, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (1 report).

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 18, 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.

• MalfunctionJul 8, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL (B)(6) GMBH, STATING, "DURING PROCEDURE SAMPLES WERE NOT COLLECTED IN THE CHAMBERS, THEY WENT TO THE TUBING. NO PATIENT COMPLICATIONS". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767943 ↗
• MalfunctionAug 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REPRESENTATIVE, THE CUSTOMER HAD 3 TIMES LATELY WHERE BLOOD/FLUID "SHOT/SPRAYED OUT" THE BACK OF THE SPECIMEN CHAMBER DURING A PROCEDURE. PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754360 ↗

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