CARBOMEDICS CARBO-SEAL VALSALVA CP-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08022057013545), received between Sep 7, 2016 and Dec 1, 2022 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. ON (B)(6) 2022, CARBOSEAL VALSALVA CONDUIT/VALVE CP-023 WAS IMPLANTED IN AORTIC POSITION THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS AORTIC ROOT REPLACEMENT (BENTALL PROCEDURE). BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, CARDIAC SIZE REMAINED ENLARGED WITH VALVULAR PROSTHESIS IN PLACE. CHEST TUBE WAS SEEN ON THE RIGHT WITH NO PNEUMOTHORAX. PATCHY BILATERAL AIRSPACE CONSOLIDATION AND SOME PLEURAL FLUID COULD BE SEEN THAT WAS A LITTLE WORSE THAN THE DAY BEFORE. BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, MINOR WORSENING OF BIBASILAR AIRSPACE CONSOLIDATION, WITH APPEARANCE OF THE CHEST OTHERWISE UNCHANGED FROM THE X-RAY PERFORMED ON (B)(6) 2022. REPORTEDLY, CARDIAC ARREST AND HEMORRHAGE STARTED ON (B)(6) 2022. THE OUTCOME WAS INDICATED AS RECOVERED/RESOLVED AFTER PATIENT UNDERWENT A SURGICAL PROCEDURE: BEDSIDE - THORACOTOMY AND THEN IN OPERATING ROOM - MEDIASTINUM EXPLORATION; AND OTHER NON-SURGICAL PROCEDURE: BEDSIDE BRONCHOSCOPY.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15896615 ↗
• InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. ON (B)(6) 2022, CARBOSEAL VALSALVA CONDUIT/VALVE CP-023 WAS IMPLANTED IN AORTIC POSITION THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS AORTIC ROOT REPLACEMENT (BENTALL PROCEDURE). BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, CARDIAC SIZE REMAINED ENLARGED WITH VALVULAR PROSTHESIS IN PLACE. CHEST TUBE WAS SEEN ON THE RIGHT WITH NO PNEUMOTHORAX. PATCHY BILATERAL AIRSPACE CONSOLIDATION AND SOME PLEURAL FLUID COULD BE SEEN THAT WAS A LITTLE WORSE THAN THE DAY BEFORE. BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, MINOR WORSENING OF BIBASILAR AIRSPACE CONSOLIDATION, WITH APPEARANCE OF THE CHEST OTHERWISE UNCHANGED FROM THE X-RAY PERFORMED ON (B)(6) 2022. REPORTEDLY, CARDIAC ARREST AND HEMORRHAGE STARTED ON (B)(6) 2022. THE OUTCOME WAS INDICATED AS RECOVERED/RESOLVED AFTER PATIENT UNDERWENT A SURGICAL PROCEDURE: BEDSIDE - THORACOTOMY AND THEN IN OPERATING ROOM - MEDIASTINUM EXPLORATION; AND OTHER NON-SURGICAL PROCEDURE: BEDSIDE BRONCHOSCOPY.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15896329 ↗
• MalfunctionMar 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2021, THE MANUFACTURER BECAME AWARE OF A PRODUCT MIS-LABELLING WITH A LIVANOVA DEVICE. IN PARTICULAR, A CARBOSEAL DEVICE MODEL CP-023 WAS IMPLANTED IN A PATIENT. HOWEVER, THE SERIAL NUMBER OF THE DEVICE THAT APPEARS IN THE PATIENT'S REGISTRATION FORM IS NOT THE SAME AS THE SERIAL NUMBER APPEARING ON THE MEDICAL RECORDS OF THE HOSPITAL. FURTHERMORE, THE DEVICE MODEL CP-023 WITH THE SAME SERIAL NUMBER SHOWED ON THE PATIENT'S IMPLANT CARD WAS RETURNED TO THE MANUFACTURER AS EXPIRED AND NOT USED FOR ANY IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579914 ↗
• InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOSEAL VALSALVA CP-023 AS PART OF AN AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A SECOND CARBOSEAL VALSALVA CP-023 ON (B)(6) 2019. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9547385 ↗
• InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOSEAL VALSALVA CP-023 AS PART OF AN AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A SECOND CARBOSEAL VALSALVA CP-023 ON (B)(6) 2019. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9547197 ↗
• DeathSep 7, 2016Delivery System Failure; Activation, Positioning or Separation Problem; Delivery System Failure; Activation, Positioning or Separation Problem

  AS PER OUR DISTRIBUTOR, THE EVENT OCCURRED LAST (B)(6) AT: HOSPITAL (B)(6), WITH THE PHYSICIAN TEAM OF (B)(6), WHO HAS A LARGE EXPERIENCE WITH THE PROCEDURE AND PRODUCTS SORIN. THE CASE WAS REPORTED AS FOLLOWS: ON SATURDAY (B)(6) 2016, DURING SURGERY AFTER PROXIMAL SUTURE THE VALVE, THE SURGEON KEEPING FIXED (WITHOUT ROTATING) THE LEVER OF THE HOLDER, PRESSED THE RELEASE BUTTON ACCORDING TO THE PRODUCT MANUAL, BUT THE HOLDER DID NOT UNFASTEN THE PROSTHESIS. BECAUSE SEVERAL ATTEMPTS TO RELEASE THE HOLDER IN ACCORDANCE WITH THE PRODUCT MANUAL INSTRUCTIONS, THE TEAM MADE AN ATTEMPT TO RELEASE BY SURGICAL INSTRUMENTATION TOOLS FOR REMOVAL HOLDER, DETACHING THE PIECE MECHANICALLY, WHICH CAME OUT WITH ONE OF THE VALVE LEAFLETS. BESIDES, ACCORDING TO THE DISTRIBUTOR THE SURGERY HAS DELAYED 30 MINUTES AND A NEW COMPETITOR'S PRODUCT HAS BEEN USED. NO DAMAGED RELATED TO THE PRODUCT OCCURRED TO THE PATIENT ACCORDING TO THE PHYSICIAN TEAM. IN ADDITION AND FOR A SECOND TIME WE WERE INFORMED THAT THE PATIENT ARRIVED AT THE HOSPITAL ON FRIDAY, IN EMERGENCY CHARACTER. HE WAS IMMEDIATELY ATTENDED AND BY EXAMS, IT WAS FOUND THAT THERE WAS AN AORTIC ANEURYSM. IN EMERGENCY CHARACTER, THE AORTIC DISSEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5931697 ↗