COR-KNOT® QUICK LOAD® 030850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850200006254), received between Jul 27, 2018 and May 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Use of Device Problem; Use of Device Problem

  NOTE: SINCE WE ARE UNABLE TO PASTE PHOTOGRAPHS OR CHARTS INTO THIS FORM, WE ARE ALSO ATTACHING A SEPARATE PDF DOCUMENT WITH THIS REPORT WHICH INCLUDES ANY FIGURES TO WHICH WE REFER IN THIS DOCUMENT. PLEASE SEE THE ATTACHED SEPARATE PDF FILED ENTITLED, "INCIDENT REPORT IMAGES FOR MEDWATCH. PDF" TO VIEW THE ASSOCIATED FIGURES. THE SUBJECT PATIENT HAD AN ORIGINAL AORTIC VALVE REPLACEMENT IN 2019 WITH PROSTHETIC VALVE THAT WAS SECURED USING COR-KNOT® TITANIUM FASTENERS. WE WERE INFORMED THAT A DIFFERENT SURGEON EXPLANTED THIS ORIGINAL PROSTHETIC VALVE IN 2022 AND REPLACED WITH ANOTHER PROSTHETIC VALVE. THE EXPLANTED VALVE SHOWED EVIDENCE OF LEAFLET PERFORATIONS. ACCORDING TO THE SURGEON WHO PERFORMED THE RE-DO PROCEDURE, THE PATIENT HAD RECOVERED WELL FROM THE PROCEDURE. NOTE: SINCE WE ARE UNABLE TO PASTE PHOTOGRAPHS OR CHARTS INTO THIS FORM, WE ARE ALSO ATTACHING A SEPARATE PDF DOCUMENT WITH THIS REPORT WHICH INCLUDES ANY FIGURES TO WHICH WE REFER IN THIS DOCUMENT. PLEASE SEE THE ATTACHED SEPARATE PDF FILED ENTITLED, "INCIDENT REPORT IMAGES FOR MEDWATCH. PDF" TO VIEW THE ASSOCIATED FIGURES. THE SUBJECT PATIENT HAD AN ORIGINAL AORTIC VALVE REPLACEMENT IN 2019 WITH PROSTHETIC VALVE THAT

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14459150 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) POST ("(B)(6)") BY A SURGEON ON (B)(6) 2021 WAS FOUND ON (B)(6) 2021 BY AN LSI EMPLOYEE. THE TWEET REPORTED, "S/P MITRAL REPAIR IN ANOTHER STATE PRESENTED W TIA AND SEVERE MR - RESIDUAL PROLAPSE. ALLERGIC TO COREKNOT? REREPAIR WITH POSTERIOR CORDS HAND TIE RING SUTURES." WHEN THE PATIENT WAS LAST SEEN, AT HIS ONE-MONTH POST-OPERATIVE VISIT, WHICH IS NOW APPROXIMATELY THREE YEARS AGO, THE PATIENT WAS REPORTED BY THE SAME SURGEON AS "DOING VERY WELL".

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12763061 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2011, AN OTHERWISE HEALTHY (B)(6) MALE BECAME SYMPTOMATIC WITH MITRAL VALVE REGURGITATION AND UNDERWENT A ROBOT ASSISTED MITRAL VALVE REPAIR UTILIZING A TRIANGULAR RESECTION OF A P1 SEGMENT AND IMPLANTATION OF A 32-MM ANNULOPLASTY RING SECURED WITH SUTURES AND COR-KNOT® TITANIUM FASTENERS. AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED MILD RESIDUAL MITRAL VALVE INSUFFICIENCY WITH NO STENOSIS. THE PATIENT DID WELL POSTOPERATIVELY. IN (B)(6) 2013, THE PATIENT FELL WHILE PLAYING TENNIS AND WAS TREATED FOR SCALP LACERATIONS. A CT SCAN OF HIS HEAD AT THE TIME WAS NORMAL. IN (B)(6) 2016, THE PATIENT EXPERIENCED TRANSIENT DOUBLE VISION AND 11 DAYS LATER PRESENTED WITH SUDDEN ONSET APHASIA AND FACIAL WEAKNESS. TISSUE PLASMINOGEN ACTIVATOR WAS ADMINISTERED SYSTEMICALLY WITH COMPLETE RESOLUTION OF THE SYMPTOMS THE FOLLOWING DAY. THE PATIENT REMAINED WELL WITH NO NEUROLOGIC SYMPTOMS AFTER TREATMENT. IN (B)(6) 2017, THE PATIENT'S CARDIAC SURGEON PUBLISHED "DELAYED METALLIC EMBOLIZATION OF A COR-KNOT FASTENER" (THORAC CARDIOVASC SURG REP 2017;6:E40-E41). IN OUR COMPANY'S ONGOING SURVEILLANCE OF PRODUCT RELATED SURGICAL LITERATURE, WE INDEPENDENTLY FOUND THIS PUBLICATION. O

  Patient problems: Foreign Body In Patient

  MAUDE report 7728834 ↗