Flexor G48187Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002481879), received between Apr 10, 2015 and Jun 14, 2022 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH LEAKED AT THE VALVE AS THE USER FLUSHED THE SHEATH. THE DEVICE COULD NOT BE USED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685153 ↗
• MalfunctionFeb 7, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND USING A FLEXOR RAABE GUIDING SHEATH, THERE WAS LEAKAGE COMING FROM THE VALVE WHEN THE OPERATOR ATTEMPTED TO PUT LIQUID INTO THE GUIDING SHEATH. THEY USED ANOTHER 4FR RAABE SHEATH WITH THE SAME LOT NUMBER, AND THE LEAKAGE HAPPENED AGAIN. ONN THEIR THIRD TRY WITH A NEW 4FR RAABE, THERE WAS NO LEAKAGE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472031 ↗
• MalfunctionApr 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623266 ↗
• MalfunctionFeb 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 01MAR2021. THE DEVICE LEAK OCCURRED PRIOR TO PATIENT CONTACT. THE DILATOR WAS IN THE SHEATH AT THE TIME OF THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314827 ↗
• MalfunctionFeb 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11259971 ↗
• MalfunctionDec 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11100365 ↗
• MalfunctionDec 2, 2020Leak/Splash; Leak/Splash

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936443 ↗
• MalfunctionAug 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE FLEXOR RAABE GUIDING SHEATH WAS OBSERVED TO BE LEAKING AT THE CONNECTING HUB UPON INSERTION INTO THE PATIENT'S ANATOMY DURING AN UNKNOWN PROCEDURE. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT REPORTED; HOWEVER, THE COMPLAINANT INDICATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813850 ↗
• MalfunctionApr 23, 2018Fluid/Blood Leak; Kinked; Fluid/Blood Leak; Kinked

  IT WAS REPORTED THAT PRIOR TO MAKING PATIENT CONTACT, THE PHYSICIAN FOUND THE HUB OF THE FLEXOR RAABE GUIDING SHEATH LEAKING. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, INCLUDING PATIENT ANATOMY AND OUTCOME, HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME. 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 7451366 ↗
• MalfunctionApr 28, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT PRIOR TO USE, THE BODY SHAFT WAS FOUND SEPARATED FROM THE VALVE.

  Patient problems: No Patient Involvement

  MAUDE report 6530462 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED BY AN INTERNATIONAL USER FACILITY THAT A PATIENT UNDERWENT A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY PROCEDURE. THE ATTENDING PHYSICIAN ATTEMPTED TO INTRODUCE THE FLEXOR RAABE GUIDING SHEATH TWICE. WHEN THE PHYSICIAN PUT THE DILATOR IN THE SHEATH, THE VALVE WAS NOT GLUED TO THE SHEATH AND IT DETACHED ITSELF. NO PIECES FROM THE BROKEN BASKET WERE LEFT IN THE PATIENT NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS OR MEDICAL INTERVENTION DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6291788 ↗
• InjuryJan 11, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM A PHYSICIAN THAT A CHECK-FLO VALVE WAS "SLACK" WITH BLOOD LEAKAGE. 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: Blood Loss

  MAUDE report 6241576 ↗
• MalfunctionApr 10, 2015Material Separation

  DURING AN UNK PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE USING THE FLEXOR CHECK-FLO INTRODUCER. THE USER PLACED THE SHEATH LEFT (COMMON FEMORAL ARTERY). UPON ATTEMPTED WITHDRAWAL, THE ATTACHMENT CAME OFF AT THE HUB. THE ANATOMY OF THE PT WAS NOT CALCIFIED OR TORTUOUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4690614 ↗