Flexor G48186Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002481862), received between Apr 25, 2017 and Feb 12, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 06FEB2025 AND 13FEB2025. THE PROCEDURE INVOLVED AN ¿ANGIO¿ WITH STENT PLACEMENT IN THE INFERIOR MESENTERIC ARTERY. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED THROUGH A 5-FRENCH COOK FLEXOR ANSEL SHEATH. OTHER MANUFACTURERS¿ 0.018-INCH WIRES AND AN ANGIOGRAPHIC CATHETER WERE ADVANCED THROUGH THE COMPLAINT DEVICE DURING THE PROCEDURE. THE ACCESS SITE WAS SCARRED FROM PREVIOUS INTERVENTIONAL PROCEDURES, THE ANATOMY WAS HEAVILY CALCIFIED, AND PREVIOUSLY PLACED STENTS WERE NOTED IN THE ILIAC ARTERIES. THE INFERIOR MESENTERIC ARTERY (IMA) WAS 80% STENOSED. REPORTEDLY, RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS REINSERTED PRIOR TO SHEATH REMOVAL. NOTHING ELSE WAS IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. THE SEPARATED FRAGMENT/RADIOPAQUE BAND REMAINS IN A TRIBUTARY OF THE MIDDLE COLIC ARTERY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21365355 ↗
• MalfunctionJun 21, 2022Peeled/Delaminated; Peeled/Delaminated

  AS INITIALLY REPORTED, THE DILATOR COULD NOT BE INSERTED INTO THE HEMOSTATIC VALVE OF A FLEXOR ANSEL GUIDING SHEATH. WHEN THE USER PUSHED THE DILATOR WITH FORCE, IT KINKED. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S LONG SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON EVALUATION OF THE DEVICE ON (B)(6) 2022, IT WAS NOTED THAT THE SHEATH WAS DELAMINATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758881 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 11095096 ↗
• MalfunctionDec 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 9452362 ↗
• MalfunctionJun 16, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A FLEXOR ANSEL GUIDING SHEATH, THAT THE SHEATH GOT SEPARATED FROM THE HUB DURING USE, SO IT WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646478 ↗
• MalfunctionMay 17, 2017Difficult to Remove

  THE INFORMATION RECEIVED INDICATED THERE WAS DIFFICULTY WITHDRAWING A 7MM X 4CM ANGIOPLASTY BALLOON BACK INTO THE SHEATH. THE PROCEDURE WAS A CONTRALATERAL APPROACH FOR ANGIOPLASTY OF THE SUPERFICIAL FEMORAL AND ILIAC ARTERIES. THE REPRESENTATIVE INDICATED THAT THE PATIENT HAD SMALLER ARTERIES TO NAVIGATE AND THERE WAS A TIGHT BIFURCATION. IT WAS REPORTED THAT AFTER THE BALLOON WAS INFLATED IT WOULD NOT COME BACK INTO THE SHEATH. THE SHEATH SEEMED KINKED AND THE BRAIDING LOOKED UNUSUAL. THE SHEATH THEN HAD TO BE COMPLETELY REMOVED WITH THE BALLOON HANGING AT THE END OF THE SHEATH. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE; HOWEVER, THE GROIN HAD TO BE PRESSED FOR A LONGER PERIOD OF TIME BECAUSE THE BALLOON WAS UNPROTECTED BY THE SHEATH AS IT CAME OUT OF THE BODY. THERE WERE NO OTHER ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. ADDITIONALLY, DEVICE IMAGES DEPICTED STRETCHING AND ELONGATION IN REGARD TO THE SHEATH.

  Patient problems: No Code Available

  MAUDE report 6572254 ↗
• MalfunctionApr 25, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CONTRAST WAS SQUIRTING OUT FROM THE FLEXOR ANSEL GUIDING SHEATH DURING A CAROTID STENTING PROCEDURE. DURING THE PROCEDURE THE PRESSURE INJECTOR WAS CONNECTED TO THE DEVICE. CONTRAST WAS OBSERVED SQUIRTING OUT FROM WHERE THE WHITE RING CONTAINING THE CHECKFLO VALVE AND SHEATH BODY MEET. THE CUSTOMER CONFIRMED THERE WERE NO ISSUES OBSERVED WHILE FLUSHING THE SHEATH INITIALLY. THE CUSTOMER STATED "THEY BELIEVE THE PRESSURE INJECTOR WAS SET AT 3ML/3ML/SEC" BUT CAN NOT CONFIRM THIS INFORMATION AS THEY WERE NOT 100% SURE. THE DEVICE IMPLICATED IN THIS REPORT WAS REPLACED WITH ANOTHER IDENTICAL DEVICE WITHOUT ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6520783 ↗