Flexor G49046Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002490468), received between May 11, 2017 and Feb 26, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination 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.

• MalfunctionFeb 26, 2020Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED 28FEB2020. AS REPORTED, THE DEVICE WAS ACTIVATED BY DIPPING INTO SALINE SOLUTION PRIOR TO USE. THE DEVICE WAS THEN INSERTED VIA RIGHT FEMORAL ACCESS FOR PLACEMENT OF AN AORTIC STENT GRAFT. COATING DETACHMENT WAS OBSERVED ONE MINUTE FOLLOWING INSERTION OF THE DEVICE. THE DEVICE WAS THEN IMMEDIATELY REMOVED AND REPLACED. POWDERED GLOVES WERE USED. VESSEL SPASMS WERE NOT REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9757038 ↗
• MalfunctionJul 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8799067 ↗
• InjuryMay 11, 2017Device Operates Differently Than Expected

  THE COMPLAINANT REPORTED THAT IT WAS IMPOSSIBLE TO ADVANCE ANOTHER MANUFACTURER'S PARAVALVULAR LEAK DEVICE (PLD) DEVICES WITH SIZE 7 FR AND 8 FR DUE TO A VERY TIGHT HEMOSTATIC VALVE. THIS PRODUCT PROBLEM, WHICH OCCURRED DURING CLOSURE OF A PARAVALVULAR LEAK IN THE AORTIC VALVE, LED TO A DELAY IN COMPLETING THE PROCEDURE AND INCREASED BLOOD LOSS. EVENTUALLY, THE HEMOSTATIC VALVE WAS COMPLETELY REMOVED AND THE PLD DEVICES WERE ADVANCED THROUGH THE SHEATH. HEMOSTASIS WAS PARTIALLY ACHIEVED MANUALLY.

  Patient problems: Blood Loss

  MAUDE report 6561683 ↗