CARBOMEDICS OPTIFORM F7-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08022057012845), received between Dec 17, 2019 and Aug 26, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. BEFORE IMPLANTING THE VALVE, SIZING WAS PERFORMED (USING CORCYM SIZER) WITHOUT ANY PROBLEM AND OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-025 WAS CHOSEN TO BE IMPLANTED. THE VALVE WAS TESTED WITHOUT ANY ISSUE BEING IDENTIFIED. AFTER IMPLANTING THE VALVE, IT WAS DETECTED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) THAT THE VALVE COULD NOT OPEN/CLOSE. REPORTEDLY, THE VALVE COULD NOT MOVE AT ALL. AS SUCH, THE VALVE WAS EXPLANTED. USING ECMO IT HAD TAKEN 100MINS (40 MINS FOR THE NORMAL SITUATION); AND REPLACING IT WITH NON-CORCYM VALVE SIZE 25. PROCEDURE WAS COMPLETED WELL, AND THE PATIENT OUTCOME WAS FINE. BASED ON ADDITIONAL INFORMATION RECEIVED, ALMOST TOTAL RESECTION OF THE NATIVE VALVE WAS PERFORMED, BUT SOME CHORDAE PAPILLARY MUSCLE WAS KEPT. REPORTEDLY, BEFORE CLOSING THE HEART, THE F7-025 VALVE WAS TESTED WITH VALVE DETECTOR AND THE RESULT WAS GOOD. AFTER CLOSING THE HEART, USING ECHOCARDIOGRAPHER, AT THE BEGINNING (ABOUT 10 SECONDS), THE VALVE FUNCTIONALITY WAS OKAY, BUT SUDDENLY THE LEAFLET WAS BLOCKED. THUS, THE DECISION TO REPLACE IT WITH A NON-CORCYM VALVE. THERE WERE NO ABNORMAL PATIENT GEOMETRIES AND NO CONCOMITANT PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15305769 ↗
• MalfunctionNov 6, 2020Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2020, A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS OPTIFORM VALVE F7-025 IN MITRAL POSITION. DURING THE PROCEDURE, A POTENTIAL LEAFLET DYSFUNCTION WAS IDENTIFIED DURING THE SUTURING OF THE VALVE (I.E. LEAFLET REPORTEDLY "STUCK") AND THE DEVICE WAS ULTIMATELY REMOVED. A NEW VALVE OF THE SAME MODEL F7-025 WAS IMPLANTED AND THE OPERATION WAS SUCCESSFULLY COMPLETED. IT IS REPORTED THAT THE LEAFLET FUNCTIONALITY WAS TESTED WITH THE DEDICATED LEAFLET TESTER PROVIDED. THERE WAS NO IMPACT FOR THE PATIENT, WHO PERFORMS AND RECOVERS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802000 ↗
• InjuryDec 17, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2019 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS OPTIFORM F7-025 MITRAL VALVE AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT AFTER THE IMPLANTATION OF HEART VALVE, WHEN THE SITE TRIED TO ROTATE THE DEVICE, THEY EXPERIENCED DIFFICULTIES AND THE VALVE DIDN'T ROTATED. THE SITE EXPLANTED THE VALVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9485056 ↗
• InjuryDec 17, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2019 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS OPTIFORM F7-025 MITRAL VALVE AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT AFTER THE IMPLANTATION OF HEART VALVE, WHEN THE SITE TRIED TO ROTATE THE DEVICE, THEY EXPERIENCED DIFFICULTIES AND THE VALVE DIDN'T ROTATED. THE SITE EXPLANTED THE VALVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9484910 ↗