Flexor G10385Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Balkin Up & Over, Contralateral Design · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002103856), received between Feb 29, 2016 and Nov 25, 2025 — classified as 1 death, 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component11
- Material Separation5
- Fluid/Blood Leak2
- Device Damaged Prior to Use1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient6
- Hemorrhage/Blood Loss/Bleeding2
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Hematoma1
- Hypovolemic Shock1
- Pneumonia1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23647911 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 23372674 ↗DeathMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR BALKIN GUIDING SHEATH SEPARATED AS THE USER WAS TRYING TO ADVANCE AN UNKNOWN STENT. BECAUSE THE SEPARATED PORTION OF THE DEVICE WAS UNABLE TO BE RETRIEVED PERCUTANEOUSLY, A SURGICAL TEAM PERFORMED A CUT-DOWN TO REMOVE THE SEPARATED PORTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; No Clinical Signs, Symptoms or Conditions; Pneumonia; Post Operative Wound Infection; Sepsis
MAUDE report 21524775 ↗MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE INVOLVING AN ARTERIOVENOUS MALFORMATION (AVM), A FLEXOR BALKIN GUIDING SHEATH LEAKED AT THE JUNCTION OF THE SHEATH AND VALVE. 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 OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19825769 ↗MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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 18970905 ↗MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED 15AUG2023. THE PROCEDURE INVOLVED IMPLANTATION OF AN ARTERIAL STENT IN A LOWER LIMB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17406244 ↗MalfunctionDec 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
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 13107972 ↗MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED 18AUG2021. THIS EVENT IS A DUPLICATE OF MANUFACTURER REPORT # 1820334-2021-01968.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12317059 ↗MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
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 12312239 ↗MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, PRIOR TO AN ENDOVASCULAR REPAIR PROCEDURE FOR AN ABDOMINAL ANEURYSM, THE HUB OF A FLEXOR BALKIN GUIDING SHEATH SEPARATED AS IT WAS PLACED OVER ANOTHER MANUFACTURER'S WIRE GUIDE. THE DILATOR WAS IN PLACE AT THE TIME OF SEPARATION. THE DEVICE WAS INTENDED TO BE PLACED IN THE COMMON ILIAC FOR ACCESS TO THE HYPOGASTRIC ARTERY. REPORTEDLY, THE SHEATH HUB SEPARATED AT THE JUNCTION WITH THE STOPCOCK. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 Patient Involvement
MAUDE report 8718394 ↗MalfunctionMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8440881 ↗MalfunctionJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), A FLEXOR BALKIN GUIDING SHEATH SEPARATED AT THE HUB. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY FOR ADVANCEMENT INTO THE LEFT ILIAC ARTERY. IT WAS REPORTED THAT THE 8FR COMPLAINT DEVICE WAS INSERTED AND FELT "TOO TIGHT". WHILE EXCHANGING THE DEVICE WITH AN UNKNOWN 6FR SHEATH, THE COMPLAINT DEVICE SEPARATED AT THE HUB. THE PROCEDURE WAS COMPLETED WITH THE UNKNOWN 6FR SHEATH. THE PATIENT WAS REPORTED TO BE STABLE, WITH DISCHARGE PLANNED. THE OUTCOME WAS REPORTED AS "GOOD". 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 Consequences Or Impact To Patient
MAUDE report 8275014 ↗MalfunctionSep 11, 2018Material Separation; Material Separation
IT WAS REPORTED, THE FLEXOR BALKIN GUIDING SHEATH BODY AND THE CHECK-FLO HUB WERE SEPARATE BEFORE THE UNSPECIFIED PROCEDURE. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7865826 ↗MalfunctionJan 10, 2018Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TIP OF THE FLEXOR BALKIN GUIDING SHEATH WAS OBSERVED TO BE DAMAGED. THE SHEATH DID NOT COME INTO CONTACT WITH A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7178306 ↗MalfunctionNov 30, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING A PROCEDURE, THE FLEXOR BALKIN GUIDING SHEATH VALVE BECAME LOOSE AND COULD NOT BE USED. THE SHEATH WAS PLACED IN THE PATIENT'S TORSO; THE PATIENT'S ANATOMY WAS REPORTED AS NORMAL. 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 7072842 ↗MalfunctionOct 3, 2017Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
A FLEXOR BALKIN GUIDING SHEATH WAS USED IN A THROMBECTOMY. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SEAL WAS FOUND TO BE LEAKING BLOOD AT THE CONNECTION OF THE VALVE AND THE PROXIMAL END OF THE SHEATH. THE PHYSICIAN USED ANOTHER DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. THE BLOOD LOSS EXPERIENCED BY THE PATIENT WAS NOT EXCESSIVE AND DID NOT REQUIRE ANY ADDITIONAL TREATMENT. 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 6911979 ↗MalfunctionJul 3, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING A CROSS OVER ACCESS FOR ATHERECTOMY PROCEDURE USING A FLEXOR BALKIN GUIDING SHEATH, WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE INTRODUCER, THE VALVE SEPARATED FROM THE SHEATH. WHEN THIS WAS NOTICED, A CLAMP WAS USED TO HOLD THE SHEATH AT THE DISTAL END PREVENTING THE INTRODUCER FROM SLIPPING INTO THE PUNCTURE HOLE. EVERYTHING WAS RETRIEVED TOGETHER. 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 6684312 ↗MalfunctionMar 10, 2017Material Separation; Material Separation
IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, THE VALVE WAS DETACHED FROM THE JOINT OF THE FLEXOR BALKIN GUIDING SHEATH IN THE PROCESS OF WITHDRAWING DILATOR. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6396777 ↗InjuryFeb 29, 2016Material Separation; Material Separation
ONCE THE INTRODUCER WAS IN PLACE DURING THE PROCEDURE AND BEING USED FOR SOME TIME, THE SIDE ARM SNAPPED OFF. 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 5466231 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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