CARBOMEDICS CARBO-SEAL VALSALVA CP-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08022057013569), received between Nov 20, 2017 and Dec 28, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2012, A CARBOSEAL VALSALVA VALVE CP-029 WAS IMPLANTED IN A PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL VALVE PVS27 ON (B)(6)2017. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR SERIOUS INJURY ON THE PATIENT HAS YET BEEN REPORTED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 18416333 ↗
• InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON 14 JAN 2012, A CARBOSEAL VALSALVA VALVE CP-029 WAS IMPLANTED IN A PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL VALVE PVS27 ON (B)(6) 2017. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR SERIOUS INJURY ON THE PATIENT HAS YET BEEN REPORTED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 18414630 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS WAS IMPLANTED ON (B)(6) 2017 AT THE AORTIC POSITION. ON (B)(6) 2018, A CROWN PRT VALVE WAS REPORTEDLY IMPLANTED AT THE SAME POSITION.

  Patient problems: No Information

  MAUDE report 7425593 ↗
• InjuryNov 20, 2017Leak/Splash; Defective Component

  (B)(6) 2017, A CARBOSEAL VALSALVA 27 MM VALVE GRAFT WAS IMPLANTED FOR A BENTALL PROCEDURE. AFTER ALL ANASTOMOSES WERE COMPLETE, IT WAS FOUND THAT THE GRAFT WAS LEAKING AT THE JUNCTURE BETWEEN THE VALVE AND THE GRAFT. THE PHYSICIAN PLACED A STITCH IN THE AREA THAT THE GRAFT WAS LEAKING, BUT THE LEAKING CONTINUED. AFTER INSPECTING THE GRAFT, THE PHYSICIAN BELIEVED THE DEVICE TO BE DEFECTIVE AND REMOVED THE PRODUCT. A 30 MM TUBE GRAFT AND 23 MM TOP HAT MECHANICAL AORTIC VALVE WERE THEN IMPLANTED. THE PHYSICIAN REPORTED THAT, AFTER REMOVING THE CARBOSEAL, A SIMPLE TUBE GRAFT WAS SEWN AT THE ANNULAR LEVEL AND THE TOP HAT WAS SEWN INTO THE GRAFT ABOVE THE ANASTOMOSIS. THIS WAS DONE TO ENSURE THE ANASTOMOSIS WAS SECURE IN THE PATIENT'S FRAGILE TISSUE. THE PATIENT WAS A MARFAN'S PATIENT WITH FRIABLE TISSUE. THE SURGERY WAS DELAYED BY 4 HOURS AS A RESULT OF THE EVENT.

  Patient problems: Connective Tissue Disease

  MAUDE report 7047621 ↗