CARBOMEDICS STANDARD M7-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08022057012715), received between Aug 16, 2016 and Jun 14, 2022 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT'S IMPLANT FORM, ON 14 FEBRUARY 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-025 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND ANOTHER M7-025 WAS IMPLANTED IN THE PATIENT INSTEAD. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14691271 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-025 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND ANOTHER M7-025 WAS IMPLANTED IN THE PATIENT INSTEAD. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14691257 ↗
• InjuryApr 21, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2011, A CARBOMEDICS STANDARD MITRAL VALVE M7-025 WAS ATTEMPTED TO BE IMPLANTED, BUT THE SURGEON NOTICED THAT ONE OF THE LEAFLETS WAS NOT MOBILE. THE VALVE WAS REMOVED AND ANOTHER DEVICE OF THE SAME VALVE TYPE AND SIZE WAS IMPLANTED. THE EXPLANTED VALVE WILL BE RETURNED TO THE MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 11702085 ↗
• InjuryApr 21, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS STANDARD MITRAL VALVE M7-025 WAS ATTEMPTED TO BE IMPLANTED, BUT AFTER IMPLANTATION THE SURGEON NOTICED THAT ONE OF THE LEAFLETS WAS NOT MOBILE. THE VALVE WAS REMOVED AND ANOTHER DEVICE OF THE SAME VALVE TYPE AND SIZE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11702072 ↗
• InjuryNov 29, 2019Fracture; Difficult to Open or Close; Fracture; Difficult to Open or Close

  ON (B)(6) 2019, A CARBOMEDICS STANDARD MITRAL M7-025 WAS INTENDED FOR A MITRAL VALVE REPLACEMENT. DURING THE IMPLANTATION, IT WAS REPORTED THAT ONE OF THE LEAFLETS DID NOT MOVE SMOOTHLY, AND REPORTEDLY 'GOT STUCK' SOMEHOW. IT WAS ATTEMPTED TO ADJUST IT, BUT THEN THE LEAFLET FELL OFF DURING ADJUSTMENT. A NEW VALVE OF THE SAME MODEL WAS IMMEDIATELY REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW M7-025 AND THE PATIENT HAD A GOOD OUTCOME AFTER SURGERY. NO PERCEIVED ISSUES WITH THE DEVICE WERE REPORTED BEFORE THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9392075 ↗
• InjuryNov 29, 2019Fracture; Difficult to Open or Close; Fracture; Difficult to Open or Close

  ON (B)(6) 2019, A CARBOMEDICS STANDARD MITRAL M7-025 WAS INTENDED FOR A MITRAL VALVE REPLACEMENT. DURING THE IMPLANTATION, IT WAS REPORTED THAT ONE OF THE LEAFLETS DID NOT MOVE SMOOTHLY, AND REPORTEDLY 'GOT STUCK' SOMEHOW. IT WAS ATTEMPTED TO ADJUST IT, BUT THEN THE LEAFLET FELL OFF DURING ADJUSTMENT. A NEW VALVE OF THE SAME MODEL WAS IMMEDIATELY REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW M7-025 AND THE PATIENT HAD A GOOD OUTCOME AFTER SURGERY. NO PERCEIVED ISSUES WITH THE DEVICE WERE REPORTED BEFORE THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9392073 ↗
• InjuryApr 3, 2019Positioning Problem; Positioning Problem

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS STANDARD MECHANICAL MITRAL VALVE M7-025. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT HAD POOR HEMODYNAMICS AFTER SUTURING. THE SITE REMOVED THE VALVE, AND IT WAS FOUND THAT THE CONNECTION POSITION BETWEEN VALVE HOLDER AND VALVE WAS REVERSED. THE SITE REPORTED THE PATIENT/USER WAS NOT AFFECTED.

  Patient problems: Mitral Insufficiency

  MAUDE report 8480601 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL M7-025 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE BUT BIGGER SIZE M7-029 ON (B)(6) 2014. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8333788 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2015 A PATIENT RECEIVED A CARBOMEDICS STANDARD MECHANICAL MITRAL VALVE, M7-025. THE MANUFACTURER WAS NOTIFIED ON THAT THE DEVICE HAD BEEN EXPLANTED ON (B)(6) 2018. THE DEVICE WAS EXPLANTED DUE TO VALVE THROMBOSIS. NO DEVICE MALFUNCTIONS WERE IDENTIFIED. THE DEVICE IS NOT AVAILABLE FOR RETURN AND ANALYSIS AS IT WAS SENT TO PATHOLOGY PER SITE EXPLANT PROTOCOL. THE PATIENT WAS DISCHARGED AND SENT HOME. INFORMATION REGARDING THE DEVICE USED AS A REPLACEMENT WAS NOT PROVIDED. NO INFORMATION REGARDING THE DEVICE FUNCTIONALITY PRIOR TO THE EVENT IS AVAILABLE.

  Patient problems: No Information; Thrombosis

  MAUDE report 8262580 ↗
• InjuryMay 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CARBOMEDICS STANDARD VALVE, SIZE 25, WAS IMPLANTED ON (B)(6) 2014 AT THE MITRAL POSITION. THE VALVE WAS EXPLANTED ON (B)(6) 2018, AND REPLACED WITH SIZE 27 CARBOMEDICS STANDARD.

  Patient problems: No Information

  MAUDE report 7492776 ↗
• InjuryMar 6, 2018Detachment Of Device Component; Detachment Of Device Component

  MANUFACTURER WAS NOTIFIED THAT AT THE TIME OF SURGERY, WHILE ROTATING THE VALVE, THE LEAFLET WAS DAMAGED AND WAS DISLODGED. THE DEVICE WAS REPLACED.

  Patient problems: No Information

  MAUDE report 7317719 ↗
• DeathAug 16, 2016Mechanical Jam; Mechanical Jam

  DURING A PROCEDURE, ONE OF THE LEAFLETS BECAME STUCK AFTER THE HEART WAS CLOSED. ON (B)(6) 2016: A PROCEDURE WAS STARTED TO PERFORM MITRAL VALVE REPLACEMENT (MVR) AND CORONARY ARTERY BYPASS GRAFTING (CABG) AT TWO SITES. FOR THE MVR PROCEDURE, THE CARBOMEDICS M7-027 (SN: (B)(4) - OBJECT OF A DIFFERENT INITIAL REPORT) WAS IMPLANTED INTO THE MITRAL ANNULUS. AFTER THE LEAFLETS WERE CONFIRMED TO BE FUNCTIONING NORMALLY USING A LEAFLET TESTER, THE HEART WAS CLOSED. WHILE THE HEART-LUNG MACHINE WAS STILL OPERATING, ONE OF THE LEAFLETS WAS FOUND TO BE STUCK. THE HEART WAS RE-OPENED AND THE VALVE WAS TESTED AGAIN USING A LEAFLET TESTER. THE RESULT WAS THAT THE LEAFLETS WERE FUNCTIONING NORMALLY. HOWEVER, AFTER THE HEART WAS CLOSED AGAIN, THE STUCK OF THE LEAFLET RECURRED. THE CARBOMEDICS M7-027 WAS REPLACED WITH THE CARBOMEDICS M7-025 (SN: (B)(4) - OBJECT OF THIS INITIAL REPORT). JUST IN CASE, THIS M7-025 VALVE WAS ROTATED TO BE IN A DIFFERENT ORIENTATION AND IMPLANTED BY A DIFFERENT SUTURING TECHNIQUE FROM THE PREVIOUS ONE. AFTER THE LEAFLETS WERE CONFIRMED TO BE FUNCTIONING NORMALLY USING A LEAFLET TESTER, THE HEART WAS CLOSED. SIMILARLY TO THE PREVIOUS VALVE, ONE OF THE LEAFLETS WAS FOUN

  Patient problems: Death

  MAUDE report 5878887 ↗