CARBOMEDICS CARBO-SEAL AP-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057013491), received between Jun 28, 2026 and Jun 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING CARBOSEAL ASCENDING AORTIC PROSTHESIS THROUGH DEVICE TRACKING. BASED ON THE INFORMATION AVAILABLE, A CARBOSEAL ASCENDING AORTIC PROSTHESIS AP-027 WAS ATTEMPTED TO BE IMPLANTED AS FOLLOWS: THE SURGEON WAS DOING A BENTALL PROCEDURE (VALVE/AORTIC ROOT REPLACEMENT). SIZED FOR A CARBOSEAL 27 (AP-027). PUT THE SUTURES IN THE ANNULUS IN THE NORMAL FASHION, FOLLOWED BY PUTTING THEM THROUGH THE SEWING CUFF OF THE VALVE. LOWERED IT DOWN INTO PLACE AND STARTED TYING IT IN ON ONE SIDE. WHEN THE SURGEON BEGAN TYING THE VALVE IN ON THE OPPOSITE SIDE, A POP WAS FELT. THROUGH INSPECTION, IT WAS NOTICED THAT THE LVOT ON THE LEFT SIZE HAD BEEN TORN AND THERE WAS THEN A HOLE. AS SUCH, THEY HAD TO REMOVE THE CARBOSEAL, REPAIR THE TISSUE AND AT THAT TIME DECIDED TO IMPLANT A GRAFT (TERUMO GELWEAVE), FOLLOWED BY A TOP HAT AORTIC VALVE S5-025 INSIDE THE GRAFT TO KEEP IT SUPRA-ANNULAR AND AWAY FROM THE REPAIR ON THE HEART AS WELL AS THE GRAFT ANASTOMOSIS. THE PATIENT RECOVERED FINE AND HAS SINCE BEEN DISCHARGED HOME. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE PATIENT HAD VERY POOR-QUALITY TISSUES WHICH WERE RELATED TO THE TEAR.

  Patient problems: Insufficient Information

  MAUDE report 25647273 ↗