Flexor G35603Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002356030), received between Mar 4, 2015 and Dec 12, 2017 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER COMPLETION OF A PERIPHERAL CORONARY INTERVENTION ANGIOPLASTY, ANOTHER MANUFACTURER'S SIX (6) FR CATHETER AND WIRE GUIDE WERE REMOVED FROM THE FLEXOR RADIAL ACCESS SET SHEATH, AND THE VALVE WAS OBSERVED TO BE BROKEN AND LEAKING BLOOD. ACCORDING TO THE INITIAL REPORTER, NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110807 ↗
• MalfunctionDec 23, 2016Leak/Splash; Leak/Splash

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA RIGHT RADIAL N A (B)(6) MALE PATIENT, THE HEMOSTATIC VALVE WAS LEAKING BLOOD BADLY WHEN THE DILATOR WAS REMOVED. THE INTRODUCER WAS EXCHANGED AND PROCEDURE CONTINUED. 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 6202291 ↗
• MalfunctionAug 3, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  UPON INSERTION INTO THE FEMALE PATIENT'S RADIAL ARTERY FOR CORONARY DIAGNOSTICS, THE SHEATH FLOWERED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5843383 ↗
• InjuryMar 16, 2016Leak/Splash; Leak/Splash

  DURING A RADIAL CORONARY ANGIOGRAM PROCEDURE ON A FEMALE PATIENT WITH PREEXISTING VARIOUS CARDIAC ISSUES, IT WAS NOTED THAT DURING THE PROCEDURE, BLOOD WAS LEAKING THROUGH THE ONE WAY VALVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5503550 ↗
• MalfunctionMar 4, 2015Leak/Splash

  WHEN THE SHEATH WAS INSERTED DURING A PCI VIA RADIAL ARTERY, IT BEGAN TO LEAK BLOOD AND TAKING IN AIR. THE SHEATH WAS IMMEDIATELY REMOVED DUE TO THE LIKELY RISK TO THE PT. A SECOND SHEATH WAS USED TO PROCEED WITH THE PROCEDURE. THE BLOOD SEEMED TO BE LEAKING FROM THE VALVE OF THE SHEATH APPEARED FROTHY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4647446 ↗