Flexor G10383Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Balkin Up & Over, Contralateral Design · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Flexor Check-Flo Balkin Up & Over introducer catheter is a guiding sheath used to reach vessels in the leg and other sites during procedures. Reports mostly describe the sheath coming apart — the material splitting, unraveling, fraying, or the hub or side arm detaching — sometimes with leaking at the hub and a tip found broken, sharp, or cracked before or during use. There are 44 reports, with no deaths and 10 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00827002103832), received between Jun 28, 2016 and Jun 23, 2026 — classified as 10 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Material Separation” (14 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.
Reports received per month
Most reported problems
Device problems
- Material Separation14
- Detachment of Device or Device Component6
- Break5
- Material Split, Cut or Torn5
- Unraveled Material5
- Fluid/Blood Leak4
- Material Deformation3
- Split3
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient10
- No Code Available8
- No Consequences Or Impact To Patient5
- No Patient Involvement3
- Device Embedded In Tissue or Plaque2
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Detachment of Device or Device Component
AS REPORTED, DURING AN ANGIOGRAM OF THE LEG VIA CONTRALATERAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY, THE HUB OF A FLEXOR BALKIN GUIDING SHEATH SEPARATED DURING REMOVAL OF THE DEVICE. THE ACCESS SITE WAS SCARRED, AND THE AORTIC BIFURCATION WAS TIGHT AND STEEP/ACUTE. PER THE REPORTER, RESISTANCE WAS ENCOUNTERED AND THE SHEATH WAS DIFFICULT TO ADVANCE UP-AND-OVER THE AORTIC BIFURCATION. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF OTHER MANUFACTURERS¿ BALLOONS AND STENT THROUGH THE SHEATH. THE HUB DID NOT LEAK. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL. UPON REMOVAL OF THE SHEATH, RESISTANCE WAS ENCOUNTERED, AND THE HUB SEPARATED. IT IS UNKNOWN IF THE HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT. RESISTANCE WAS ALSO ENCOUNTERED AS THE SHAFT OF THE SHEATH WAS REMOVED WITH A CLAMP, AFTER THE HUB SEPARATED. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. 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 25594945 ↗MalfunctionJan 13, 2026Detachment 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 24056662 ↗MalfunctionDec 15, 2025Unraveled Material; Unraveled Material
AS REPORTED, PRIOR TO USE FOR A PROCEDURE INVOLVING AN ARTERIAL OCCLUSION OF THE LOWER EXTREMITIES, A FLEXOR BALKIN GUIDING SHEATH WAS FOUND TO BE DAMAGED AND UNUSABLE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT PART OF THE SHEATH IS UNRAVELED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23809675 ↗MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, PRIOR TO USE WHILE FLUSHING THE DEVICE WITH SALINE, THE SIDE-ARM SEPARATED FROM A FLEXOR BALKIN GUIDING SHEATH'S HUB. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23598097 ↗MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE INVOLVING RECANALIZATION OF AN OCCLUDED ARTERY IN THE LEG, A FLEXOR BALKIN GUIDING SHEATH LEAKED AT THE HUB. REPORTEDLY, AS THE SHEATH WAS "TURNED UP", THE HUB LEAKED, AND BLOOD WAS "SPURTING" FROM THE DEVICE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843414 ↗MalfunctionFeb 21, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE TIP OF A FLEXOR BALKIN GUIDING SHEATH WAS DAMAGED AND SHARP. THE SHEATH WAS REPORTEDLY INSERTED INTO THE FEMORAL ARTERY AND ADVANCED TO THE DESIRED POSITION FROM AN IPSILATERAL APPROACH, OVER ANOTHER MANUFACTURER¿S WIRE GUIDE. THE ACCESS SITE WAS NOT SCARRED, THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED, AND THE BIFURCATION WAS NOT STEEP. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE DEVICE. ANOTHER MANUFACTURER¿S CONTRAST CATHETER WAS USED THROUGH THE SHEATH, AND WHILE INJECTING CONTRAST, BLEEDING WAS NOTED. THE SHEATH WAS THEN REMOVED FROM THE PATIENT, AND THE USER NOTED THAT THE SHEATH TIP WAS DAMAGED. PER THE USER, THE SHEATH TIP SCRAPED THE VESSEL WALL. RESISTANCE WAS NOT ENCOUNTERED DURING REMOVAL OF THE SHEATH. ANOTHER SHEATH WAS USED TO PLACE A STENT AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. 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: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21434523 ↗MalfunctionJun 13, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance
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 19532519 ↗MalfunctionMar 25, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED ON 20JUN2024. THE TIP WAS FOUND BROKEN UPON REMOVAL FROM THE PACKAGING.
Patient problems: Insufficient Information
MAUDE report 18969912 ↗MalfunctionJul 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
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 17327756 ↗MalfunctionJun 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS RECEIVED 09JUL2023. THE ACCESS SITE WAS NOT SCARRED. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. ANOTHER MANUFACTURER'S WIRE WAS USED DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED INSERTION OF THE DEVICE. UPON RETURN AND EVALUATION OF THE DEVICE, THE DILATOR TIP WAS NOT SPLIT, BUT WAS RATHER FOLDED INWARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17226948 ↗MalfunctionMar 17, 2023Break; Peeled/Delaminated; Unraveled Material; Material Split, Cut or Torn; Break; Peeled/Delaminated; Unraveled Material; Material Split, Cut or Torn
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 16565321 ↗MalfunctionAug 25, 2022Break; Peeled/Delaminated; Unraveled Material; Break; Peeled/Delaminated; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN THE SUPERFICIAL FEMORAL ARTERY, A FLEXOR BALKIN GUIDING SHEATH UNRAVELED. THE DEVICE WAS PLACED WITHIN THE LEFT ILIAC ARTERY. THE ANATOMY WAS NOT CALCIFIED, TORTUOUS, OR SCARRED. THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS REPORTEDLY TOTALLY OCCLUDED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH; HOWEVER, PER THE REPORTER, THE SHEATH FELT LIKE IT KINKED WHEN A CATHETER WAS PASSED THROUGH THE DEVICE THE FIRST TIME. THE PHYSICIAN PULLED AND PUSHED AND GAINED MANEUVERABILITY; HOWEVER, THE SHEATH WOULD STILL GET "HUNG UP". WHEN THE PROCEDURE WAS COMPLETED, THE PHYSICIAN REMOVED THE SHEATH WITHOUT THE DILATOR IN PLACE. A FINE PIECE OF WIRE WAS NOTED TO BE HANGING FROM THE TIP OF THE SHEATH AFTER IT WAS REMOVED FROM THE PATIENT. THE NURSE STRETCHED THE WIRE/FILAMENT AND IT BROKE OFF. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 15292502 ↗MalfunctionJul 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOGRAPHY, BALLOON DILATION, AND STENT IMPLANTATION WITHIN THE LOWER EXTREMITY, THE HUB OF A FLEXOR BALKIN GUIDING SHEATH LEAKED BLOOD. MINIMAL BLOOD LOSS WAS REPORTED. ALTHOUGH THE USER REPORTED THAT NO OTHER DEVICES WERE USED DURING THE PROCEDURE AND THAT NOTHING WAS IN THE HUB AT THE TIME OF THE EVENT, A VIDEO PROVIDED BY THE CUSTOMER SHOWS AN UNSPECIFIED WIRE GUIDE IN THE HUB OF THE SHEATH WHEN THE LEAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15086016 ↗MalfunctionMay 19, 2022Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, WHILE UNPACKING A SHIPPING CONTAINER, THE SEAL WAS FOUND TO BE MISSING FROM A FLEXOR BALKIN GUIDING SHEATH'S STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14437973 ↗MalfunctionMar 9, 2022Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR BALKIN GUIDING SHEATH SPLIT. THE DEVICE WAS REPORTEDLY UNABLE TO BE INSERTED INTO THE PATIENT. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT THE SHEATH TIP APPEARS TO BE SPLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 13712189 ↗MalfunctionFeb 5, 2021Material Frayed; Material Frayed
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11284950 ↗MalfunctionDec 13, 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 9466671 ↗MalfunctionSep 5, 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 8966392 ↗InjuryJul 30, 2019Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019: THE PHYSICIAN OBTAINED ACCESS IN THE LEFT GROIN FOR TREATMENT OF THE RIGHT SIDE. THE PHYSICIAN BALLOONED AND USED A ¿CSI¿ ON THE EXTERNAL ILIAC, THROUGH THE COMPLAINT DEVICE. AFTER TREATING THE STENOSIS, THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH AND WHEN HE ¿TUGGED¿ ON THE DEVICE, IT TORE IN HALF. HALF OF THE DEVICE WAS OUTSIDE OF THE BODY WITH THE WIRE AND HALF REMAINED IN THE BODY. A SECOND ACCESS WAS OBTAINED ON THE RIGHT SIDE AND THE USER WAS ABLE TO RETRIEVE THE REMAINING HALF OF THE COMPLAINT DEVICE WITH A NEW 10 FRENCH (UNKNOWN MANUFACTURER) SHEATH AND SNARE. HEMATOMAS WERE PRESENT BILATERALLY AFTER THE PROCEDURE, PER THE REPORTER.
Patient problems: No Code Available
MAUDE report 8842222 ↗InjuryJun 24, 2019Material 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 Code Available
MAUDE report 8727773 ↗MalfunctionMay 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8633898 ↗InjuryApr 2, 2019Material Separation; Material Separation
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR BALKIN GUIDING SHEATH BROKE APART UPON REMOVAL FROM AN (B)(6) MALE'S FEMORALIS COMMUNIS. EIGHTY PERCENT OF THE DEVICE REMAINED IN THE PATIENT'S PELVIC ARTERY. THESE PORTIONS WERE SURGICALLY REMOVED. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: No Code Available
MAUDE report 8475602 ↗MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8445676 ↗MalfunctionFeb 28, 2019Material 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 Patient Involvement
MAUDE report 8379481 ↗MalfunctionNov 5, 2018Material Separation; Material Separation
IT WAS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THE HUB BECAME LOOSE FROM THE BODY OF THE FLEXOR BALKIN GUIDING SHEATH. THE HUB COMING OFF WAS OBSERVED AS THE COMPLAINT DEVICE WAS BEING REMOVED FROM THE PATIENT'S ANATOMY. ACCORDING TO THE INITIAL REPORTER, THE DILATOR WAS NOT INSERTED INTO THE SHEATH AS IT WAS BEING REMOVED. IT WAS SPECIFIED, HOWEVER THAT A WIRE GUIDE HAD BEEN IN THE LUMEN OF THE SHEATH, BUT REMOVED JUST BEFORE THE REMOVAL OF FLEXOR BALKIN GUIDING SHEATH. IT WAS FURTHER REPORTED THAT THE CASE WAS SUCCESSFUL. 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 8038632 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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