Mammotome revolve MST0809Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841911100713), received between Feb 28, 2019 and Nov 2, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY REP DURING PROCEDURE DURING BIOPSY, RAD WENT INTO INJECT ADDITIONAL LIDO AND THE LIDO SHOT OUT OF THE BACK OF THE SPECIMEN COLLECTION CHAMBER. AS A RESULT, A TISSUE SAMPLE AS HANGING OUT OF THE BACK OF THE COLLECTION CHAMBER AND BOTH THE RAD AND TECH HAD GOTTEN SPRAYED WITH FLUID. THEY WERE ABLE TO COMPLETE THE BIOPSY BUT WANTED TO MAKE NOTE OF THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9269834 ↗
• MalfunctionJul 2, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, THE PROBE TOOK THREE ATTEMPTS TO LATCH TO THE HOLSTER. LATCHED AFTER TURNING THE THUMB WHEEL AND HOLDING IT DOWN. DURING THE PROCEDURE IT DID NOT COLLECT TISSUE IN THE CHAMBER BUT ENDED UP PUTTING THE TISSUE INTO THE CANISTER. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752367 ↗
• MalfunctionMar 21, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM SALES, STATING, DURING PROCEDURE NO TISSUE WAS ACQUIRED. THIS IS DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8441927 ↗
• MalfunctionMar 1, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT STATING, "PROBE SUCKED TISSUE INTO THE CANISTER INSTEAD OF THE INDIVIDUAL CHAMBERS". NO PATIENT CONSEQUENCES REPORTED. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381515 ↗
• MalfunctionFeb 28, 2019Unsealed Device Packaging; Unsealed Device Packaging

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE DEVICOR MEDICAL FRANCE, STATING BEFORE THE PROCEDURE THE DISPOSABLE BOX WAS ALREADY OPEN AND THE DEVICE NOT STERILE. NO PATIENT INVOLVEMENT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380151 ↗

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