Flexor G48189Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002481893), received between Aug 18, 2016 and Mar 10, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fluid/Blood Leak

  AS REPORTED, DURING AN UPPER EXTREMITY FISTULAGRAM, A FLEXOR ANSEL GUIDING SHEATH LEAKED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL VEIN TO TARGET THE LEFT BRACHIAL VEIN. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. AS THE PHYSICIAN ATTEMPTED TO ADMINISTER 50/50 CONTRAST/SALINE THROUGH THE SIDE PORT, THE DEVICE LEAKED FROM THE VALVE, AROUND ANOTHER MANUFACTURER¿S 0.035-INCH WIRE AND A COOK 035 CXI CATHETER, WHICH WERE INSIDE THE SHEATH. CONTRAST WAS THEN ADMINISTERED THROUGH THE CATHETER INSTEAD OF THE SHEATH, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557007 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  AS REPORTED, DURING AN UNSPECIFIED VASCULAR PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH LEAKED CONTRAST/SALINE FROM THE CHECK-FLO VALVE WHEN THE DOCTOR WAS TAKING A PICTURE. ACCESS WAS OBTAINED IN THE RIGHT GROIN, AND A CONTRALATERAL APPROACH WAS USED TO TREAT THE LEFT TIBIAL VESSELS. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494707 ↗
• MalfunctionJun 18, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561276 ↗
• MalfunctionJan 19, 2024

  ADULT MALE WITH HISTORY OF NON-HEALING WOUND, RIGHT FOOT. PROCEDURE: RIGHT LOWER EXTREMITY ANGIOGRAM. THE TIP OF THE FLEXOR CHECK-FLO INTRODUCER WAS PARTIALLY SEALED, MAKING THE SHEATH UNUSABLE. REMOVED WITHOUT KNOWN HARM TO PATIENT, ANOTHER DEVICE USED WITHOUT DIFFICULTY. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, FLEXOR (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542503 ↗
• MalfunctionAug 25, 2023Break; Unraveled Material; Break; Unraveled Material

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

  Patient problems: Insufficient Information

  MAUDE report 17628244 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569198 ↗
• MalfunctionAug 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019. AS REPORTED, DUE TO RESISTANCE EXPERIENCED ON REMOVAL OF THE DEVICE, TRACTION WAS APPLIED TO THE DEVICE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893681 ↗
• InjuryMar 15, 2019Unraveled Material; Unraveled Material

  IT WAS REPORTED, A FEMALE PATIENT OF UNKNOWN AGE WITH HISTORY OF BELOW THE KNEE VASCULAR DISEASE, WAS UNDERGOING ANGIOPLASTY OF THE LOWER LEFT LEG USING A FLEXOR ANSEL GUIDING SHEATH. DURING THE PROCEDURE ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE COMPLAINT SHEATH WAS ADVANCED TO LEFT THE POPLITEAL ARTERY AND THEY WERE TRYING TO CROSS ANTERIOR TIBIAL OF THE LEFT LEG. OTHER DEVICES USED THROUGH THE COMPLAINT SHEATH INCLUDED ANOTHER MANUFACTURER'S CATHETER AND WIRE. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION DUE TO PATIENT'S SCARRED AND CALCIFIED ANATOMY, AND COULD NOT COMPLETE THE PROCEDURE. THE COMPLAINT SHEATH HAD BEEN IN PLACE APPROXIMATELY THIRTY MINUTES WHEN THE PROCEDURE WAS ABORTED. UPON REMOVAL OF THE COMPLAINT SHEATH OVER THE WIRE, IT STARTED TO "UNWIND" IN TWO PLACES ON THE SHAFT. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL. ADDITIONALLY, IT WAS REPORTED RESISTANCE WAS FELT DURING INSERTION AND REMOVAL OF THE COMPLAINT SHEATH. THE COMPLAINT SHEATH WAS ABLE TO BE RETRIEVED WITH FORCEPS AND THE PATIENT IS REPORTEDLY DOING FINE/STABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE

  Patient problems: No Code Available

  MAUDE report 8426156 ↗
• MalfunctionJan 23, 2018Delamination; Difficult to Advance; Delamination; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO USE, THE FLEXOR ANSEL GUIDING SHEATH DILATOR ENCOUNTERED RESISTANCE WHILE ADVANCING THROUGH THE SHEATH. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER FLEXOR ANSEL GUIDING SHEATH WAS OPENED AND UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ON 22DEC2017 DURING INVESTIGATION OF THE COMPLAINT DEVICE, IT WAS OBSERVED THAT THE TNRT LINER WAS DELAMINATING AT THE PROXIMAL FLARED SECTION OF THE SHEATH TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213788 ↗
• MalfunctionJan 23, 2018Failure to Advance; Delamination; Failure to Advance; Delamination

  IT WAS REPORTED THAT DURING PREPARATION FOR A LASER ATHERECTOMY, THE FLEXOR ANSEL GUIDING SHEATH DILATOR WOULD NOT ADVANCE THROUGH THE VALVE. ACCORDING TO THE INITIAL REPORTER, THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER FLEXOR ANSEL GUIDING SHEATH WAS OPENED AND UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ON 22DEC2017 DURING INVESTIGATION OF THE COMPLAINT DEVICE, IT WAS OBSERVED THAT THE TNRT LINER WAS DELAMINATING AT THE PROXIMAL FLARED SECTION OF THE SHEATH TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213765 ↗
• MalfunctionAug 15, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING PREPARATION FOR AN UNKNOWN PROCEDURE, UPON OPENING THE PACKAGE, THERE WAS A CUT/TEAR OBSERVED AT THE SHAFT-HUB JUNCTION OF THE FLEXOR ANSEL GUIDING SHEATH. THE DEVICE WAS NOT USED, THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS COMPLAINT DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6794453 ↗
• MalfunctionMay 16, 2017Failure to Advance; Split

  IT WAS REPORTED THAT THE SHEATH'S DILATOR WOULD NOT GO INTO THE HUB, AND A RETURNED PHOTO SHOWED THAT THE TIP OF THE DILATOR WAS CRIMPED AND SPLIT. THIS HAPPENED PRIOR TO USE, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571003 ↗
• InjuryMay 4, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY WITH A FLEXOR ANSEL GUIDING SHEATH, THE SHEATH SEPARATED DURING PASSAGE. ON TWO SEPARATE 5X90 COOK SHEATHS PHYSICALLY SEPARATED DURING PASSAGE WHILE USING THE COOK ANGLED GLIDE. A THIRD 5X90 COOK SHEATH WAS OPENED AND ANOTHER MANUFACTURER'S GLIDE WIRE WAS PASSED WITHOUT TROUBLE, THE SHEATH DID NOT SEPARATE OR STICK TO THE WIRE. IT WAS REPORTED THAT THE END USERS STARTED GETTING ACCESS IN THE RIGHT GROIN WITH ANOTHER MANUFACTURER'S DEVICE. THE END USERS REPORT USING NON LATEX, NON POWDERED GLOVES. ONCE THEY GOT ACCESS, THEY ADVANCED THE COOK UNIGLIDE 260CM ANGLED STIFF WIRE UP AND OVER. THE TECH REPORTED THEY THEN FLUSHED THE WIRE, DIPPED THE TIP OF THE WIRE IN SALINE, AND WET THE WIRE WITH WET GAUZE TO ACTIVATE THE HYDROPHILIC COATING. THEY THEN OPENED THE 5X90 ANSEL SHEATH AND FLUSHED ALL COMPONENTS. IT WAS NOTICED THAT THE END OF THE DILATOR WASN'T COMPLETELY OPENED AT THE TIP, SO THE PHYSICIAN SNIPPED THE TIP OF THE DILATOR. THE PHYSICIAN BEGAN ADVANCING THE SHEATH ON THE UNIGLIDE. THE TECH HELD THE END OF THE WIRE WHILE THE PHYSICIAN ADVANCED THE SHEATH NEAR THE ACCESS SITE. THE PHYSICIAN THEN MET RESISTANCE, THE SHEATH WAS N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6545848 ↗
• MalfunctionMay 4, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY WITH A FLEXOR ANSEL GUIDING SHEATH, THE SHEATH SEPARATED DURING PASSAGE. ON TWO SEPARATE 5X90 COOK SHEATHS PHYSICALLY SEPARATED DURING PASSAGE WHILE USING THE COOK ANGLED GLIDE. A THIRD 5X90 COOK SHEATH WAS OPENED AND ANOTHER MANUFACTURER'S GLIDE WIRE WAS PASSED WITHOUT TROUBLE, THE SHEATH DID NOT SEPARATE OR STICK TO THE WIRE. IT WAS REPORTED THAT THE END USERS STARTED GETTING ACCESS IN THE RIGHT GROIN WITH THE ANOTHER MANUFACTURER'S DEVICE. THE END USERS REPORT USING NON LATEX, NON POWDERED GLOVES. ONCE THEY GOT ACCESS, THEY ADVANCED THE COOK UNIGLIDE 260CM ANGLED STIFF WIRE UP AND OVER. THE TECH REPORTED THEY THEN FLUSHED THE WIRE, DIPPED THE TIP OF THE WIRE IN SALINE, AND WET THE WIRE WITH WET GAUZE TO ACTIVATE THE HYDROPHILIC COATING. THEY THEN OPENED THE 5X90 ANSEL SHEATH AND FLUSHED ALL COMPONENTS. IT WAS NOTICED THAT THE END OF THE DILATOR WASN'T COMPLETELY OPENED AT THE TIP, SO THE PHYSICIAN SNIPPED THE TIP OF THE DILATOR. THE PHYSICIAN BEGAN ADVANCING THE SHEATH ON THE UNIGLIDE. THE TECH HELD THE END OF THE WIRE WHILE THE PHYSICIAN ADVANCED THE SHEATH NEAR THE ACCESS SITE. THE PHYSICIAN THEN MET RESISTANCE, THE SHEATH W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6545844 ↗
• InjuryAug 18, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED DURING A PERIPHERAL LEG INTERVENTION, WHEN ATTEMPTING TO REMOVE THE SHEATH FROM THE PATIENT AS THE BRAIDING OF THE SHEATH CAME OUT. IN ADDITION, WE WERE ADVISED THAT THE USER DID NOT HAVE THE DILATOR IN THE SHEATH WHEN ATTEMPTING TO REMOVE IT. A SECTION OF THE SHEATH DETACHED INSIDE THE PATIENT'S BODY AND THE PATIENT HAD TO BE SENT TO THE OPERATING ROOM FOR FOREIGN BODY REMOVAL. THE OUTCOME OF THE RETRIEVAL OF THE SHEATH FRAGMENT IS UNKNOWN AS OF THE DATE OF THIS REPORT. THE CUSTOMER REPORTEDLY SAID ONLY THAT THE PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 5886112 ↗