Regent™ 21AGN-751Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067044297), received between Jun 23, 2025 and Sep 25, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Detachment of Device or Device Component

  It was reported that on (b)(6) 2026, a 21mm SJM Regent Heart Valve was chosen for a procedure. During procedure, the leaflet got broken into one piece and the dislodged piece was recovered from the patient. A new replacement device was implanted. There was no delay in the procedure. The patient was reported recovering.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898059 ↗
• MalfunctionJul 8, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. AFTER IMPLANTATION SURGEON FOUND THAT VALVE IS NOT ROTATING. THE VALVE GOT EXPLANTED AND IMPLANTED A NEW 19MM SJM REGENT HEART VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753555 ↗
• InjuryFeb 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR A SURGERY OF ACUTE AORTIC DISSECTION TYPE A. THEY INITIALLY PLANNED FOR AORTIC VALVE REPLACEMENT (AVR) AND SUPRA CORONARY ASCENDING AORTIC REPLACEMENT. AFTER COMPLETING THE AVR PROCEDURE AND WHILE PREPARING FOR REPLACEMENT OF ASCENDING AORTA, SURGEON FOUND A SMALL TEAR IN RIGHT CORONARY CUSP. THEREFORE THEY DECIDED TO PERFORM BENTALL OPERATION. THE 21MM VALVE WAS EXPLANTED AND A NEW 19MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24240976 ↗
• MalfunctionDec 1, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE AORTIC ANULUS WAS HEAVILY CALCIFIED WITH SMALL ANNULUS AND THE PHYSICIAN IMPLANTED THE VALVE. WHILE ROTATION THE PHYSICIAN FACED DIFFICULTY TO ROTATE AND LEAFLET WERE DISLODGED INTO MULTIPLE PIECES DUE TO TIME CONSTRAIN AND WENT FOR SMALLER SIZE AND COMPLETE THE PROCEDURE. ALL THE PIECES WERE RECOVERED FROM THE PATIENT. A NEW 19MM VALVE WAS SUCCESSFULLY IMPLANTED WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687707 ↗
• MalfunctionNov 11, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING DEVICE PREPARATION, THE LEAFLETS MOVING NORMALLY WHEN TESTED AND LEAFLET FUNCTION TESTED BY LEAFLET TESTER. DURING PROCEDURE, THE NATIVE VALVE WAS EXCISED AND CONFIRMED THE ANNULUS SIZE AS 21MM WITH SIZER SET. THEN 21 VALVE WAS IMPLANTED. AFTER THAT IT WAS NOTED THAT THE VALVE LEAFLETS DIDN¿T MOVE PROPERLY, SO TRIED TO ROTATE THE VALVE BUT IT GOT STRUCK AND NOT ABLE TO ROTATE. THEY EXPLANTED THE VALVE AND IMPLANTED A NEW 19MM SJM REGENT HEART VALVE WHILE PATIENT WAS BYPASS. THERE WAS SOME DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526034 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER THE HEART VALVE WAS IMPLANTED, IT FELT LIKE SOMETHING WAS STUCK, AND WHEN IT WAS ROTATED, ONE OF THE LEAFLET CAME OFF. THERE WAS RESISTANCE FELT WHEN ROTATING. THE LEAFLET WAS RECOVERED FROM THE PATIENT. A NEW NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS NO REPORTED ADVERSE EVENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352795 ↗
• MalfunctionJul 11, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, AFTER THE VALVE WAS IMPLANTED, THE VALVE BROKE INTO MULTIPLE PIECES WHILE TRYING TO ROTATE IT. THE PHYSICIAN NOTED THAT THEY FELT DIFFICULTY ROTATING THE VALVE. THE DEVICE AND ALL PEIECES WERE REMOVED AND REPLACED BY ANOTHER 21MM REGENT VALVE TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481041 ↗
• InjuryJun 23, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT VALVE WAS SUCCESSFULLY IMPLANTED. POST-IMPLANT, INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED A MODERATE PARAVALVULAR LEAK (PVL) AT THE LEFT CORONARY CUSP (LCC) REGION. IT WAS DECIDED TO REPLACE THE VALVE WITH ANOTHER 21MM REGENT VALVE. UPON EXPLANTATION OF THE AORTIC PROSTHESIS, A DEFECT IN THE PERI-MEMBRANOUS SEPTUM WAS IDENTIFIED BENEATH THE VALVE ANNULUS, WHICH WAS THE LIKELY CAUSE OF THE PVL. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT IS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22308439 ↗