Flexor G13539Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002135390), received between May 15, 2017 and Oct 29, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Crack” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Flaked; Flaked

  AS REPORTED, UNSPECIFIED COOK FLEXOR SHUTTLE LONG SHEATHS WERE USED FOR THREE CASES INVOLVING PLACEMENT OF NEUROVASCULAR FLOW-DIVERTING STENTS WITHIN THE PAST SIX YEARS, AFTER WHICH THE PATIENTS DEVELOPED IATROGENIC GRANULOMATOUS INFLAMMATORY REACTIONS TO HYDROPHILIC COATING MATERIAL EMBOLIZATION. THE THREE CASES WILL BE REPORTED UNDER PATIENT IDENTIFIERS (B)(6). ANOTHER MANUFACTURER¿S CATHETERS WERE ALSO USED DURING THE PROCEDURES, AS WELL AS UNSPECIFIED STENTS. A FEW WEEKS AFTER THE PROCEDURES, THE PATIENTS DEVELOPED NEUROLOGICAL DEFICITS, SECONDARY TO MULTIPLE TINY NODULES OF INFLAMMATION IN THE AREA OF THE BRAIN SUPPLIED BY THE ARTERIES INVOLVED IN THE PROCEDURES. REPORTEDLY, THE USER BELIEVES THAT SOME OF THE COATING MATERIAL OF ANY OF THE DEVICES USED DURING THE PROCEDURES MAY HAVE DETACHED AND EMBOLIZED DISTALLY, CAUSING INFLAMMATION IN SENSITIVE PATIENTS. PER THE REPORTER, THE COATING OF THE UNKNOWN STENT IS NOT BELIEVED TO BE THE CULPRIT IN ALL THREE CASES, AS ONE CASE ALSO INVOLVED TERRITORY OF BRANCHES PROXIMAL TO THE LOCATION OF THE STENT. THE USER SUSPECTS THAT THE EMBOLIZED PARTICLES MAY HAVE ORIGINATED FROM THE SHEATH OR OTHER MANUFACTURER¿S GUIDING CATHETERS, WHICH

  Patient problems: Diplopia/Double Vision; Foreign Body In Patient; Granuloma; Unspecified Nervous System Problem

  MAUDE report 23417371 ↗
• InjuryOct 29, 2025Flaked; Flaked

  AS REPORTED, UNSPECIFIED COOK FLEXOR SHUTTLE LONG SHEATHS WERE USED FOR THREE CASES INVOLVING PLACEMENT OF NEUROVASCULAR FLOW-DIVERTING STENTS WITHIN THE PAST SIX YEARS, AFTER WHICH THE PATIENTS DEVELOPED IATROGENIC GRANULOMATOUS INFLAMMATORY REACTIONS TO HYDROPHILIC COATING MATERIAL EMBOLIZATION. THE THREE CASES WILL BE REPORTED UNDER PATIENT IDENTIFIERS (B)(6). ANOTHER MANUFACTURER¿S CATHETERS WERE ALSO USED DURING THE PROCEDURES, AS WELL AS UNSPECIFIED STENTS. A FEW WEEKS AFTER THE PROCEDURES, THE PATIENTS DEVELOPED NEUROLOGICAL DEFICITS, SECONDARY TO MULTIPLE TINY NODULES OF INFLAMMATION IN THE AREA OF THE BRAIN SUPPLIED BY THE ARTERIES INVOLVED IN THE PROCEDURES. REPORTEDLY, THE USER BELIEVES THAT SOME OF THE COATING MATERIAL OF ANY OF THE DEVICES USED DURING THE PROCEDURES MAY HAVE DETACHED AND EMBOLIZED DISTALLY, CAUSING INFLAMMATION IN SENSITIVE PATIENTS. PER THE REPORTER, THE COATING OF THE UNKNOWN STENT IS NOT BELIEVED TO BE THE CULPRIT IN ALL THREE CASES, AS ONE CASE ALSO INVOLVED TERRITORY OF BRANCHES PROXIMAL TO THE LOCATION OF THE STENT. THE USER SUSPECTS THAT THE EMBOLIZED PARTICLES MAY HAVE ORIGINATED FROM THE SHEATH OR OTHER MANUFACTURER¿S GUIDING CATHETERS, WHICH

  Patient problems: Foreign Body In Patient; Granuloma; Muscle Weakness/Atrophy; Unspecified Nervous System Problem

  MAUDE report 23417157 ↗
• MalfunctionJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 12JUL2023 AND WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE DEVICE, WHICH IS BELIEVED TO HAVE BEEN FLUSHED NORMALLY, DID NOT MAKE PATIENT CONTACT, AS THE PROBLEM WAS OBSERVED DURING PREPARATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317152 ↗
• MalfunctionFeb 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DIAGNOSTIC EXTRACRANIAL AND INTRACRANIAL ANGIOGRAM FOR FOUR (4) VESSELS, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DISTAL RADIOPAQUE BAND WAS IN THE INCORRECT POSITION (NOT LOCATED IN THE DISTAL TIP). THE ANGIOGRAM WAS UNSUCCESSFUL AND HAD TO BE RE-PERFORMED FOR THE PATIENT'S INTRACRANIAL LESION. THE SHEATH WAS PLACED IN THE CAROTID ARTERY; AN ANGIOCATHETER (MANUFACTURER UNSPECIFIED) WAS UTILIZED THROUGH THE LUMEN OF THE SHEATH. ANOTHER MANUFACTURER'S WIRE GUIDE WAS PLACED AND REMOVED WITH THE SHEATH DURING THE EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7285093 ↗
• InjuryFeb 20, 2018Material Separation; Uncoiled; Material Separation; Uncoiled

  IT WAS REPORTED THAT DURING A CAROTID STENTING PROCEDURE, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS REMOVED OVER A WIRE WITHOUT A DILATOR AND BECAME COMPLETELY UNCOILED. THE SHEATH SEPARATED IN HALF WITH THE COILING EXPOSED. THE DISTAL PORTION OF THE SHEATH REMAINED WITHIN THE ABDOMINAL AORTA AND ILIAC, AND WAS REQUIRED TO BE SURGICALLY REMOVED. IT WAS NOTED THAT THE PATIENT'S VESSELS WERE LIKELY CALCIFIED. ACCESS WAS GAINED FROM THE PATIENT'S GROIN; A WIRE GUIDE WAS UTILIZED THROUGH THE SHEATH DURING THE EVENT. THE FOLLOWING DEVICES (UNSPECIFIED MANUFACTURER) WERE ALSO INSERTED INTO THE LUMEN OF THE SHEATH PRIOR TO REMOVAL: STENTS, BALLOON, AND POSSIBLY A CAROTID FILTER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7282749 ↗
• MalfunctionJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A NEURO ANGIOGRAPHY, THE DISTAL TIP OF THE RADIOPAQUE BAND OF TWO FLEXOR SHUTTLE TIBIAL GUIDING SHEATHS WITH THE SAME LOT NUMBER WAS OBSERVED TO BE INCORRECTLY MARKED. 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 7196130 ↗
• MalfunctionJan 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT UPON INSPECTION, THE RADIOPAQUE BAND WAS OBSERVED TO BE IN THE INCORRECT LOCATION ON TWO FLEXOR SHUTTLE TIBIAL GUIDING SHEATHS OF THE SAME LOT NUMBER. THE DEVICES WERE NOT UTILIZED DURING A PROCEDURE; NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7190375 ↗
• MalfunctionJan 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ANGIOGRAM, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH RADIOPAQUE BAND WAS OBSERVED TO BE IN THE INCORRECT LOCATION ON THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT AS A RESULT. 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 7185659 ↗
• MalfunctionMay 17, 2017Crack

  THE REPORTED INFORMATION INDICATED THAT THE HUB WAS NOTED TO BE CRACKED UPON OPENING THE PACKAGE. THIS OCCURRED PRIOR TO USE, SO THERE WERE NO PATIENT INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6573041 ↗
• MalfunctionMay 17, 2017Crack; Device Damaged Prior to Use

  THE REPORTED INFORMATION INDICATED THAT THE HUB WAS NOTED TO BE CRACKED UPON OPENING THE PACKAGE. THIS OCCURRED PRIOR TO USE, SO THERE WERE NO PATIENT INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 6572899 ↗
• MalfunctionMay 15, 2017Failure to Advance

  THE END USER STATED THAT ONCE THE DEVICE WAS IN PLACE, OTHER 6 FR DEVICES WOULD NOT PASS THROUGH IT . THE DEVICE WAS REMOVED AND AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO NOTED THAT THE COIL AND INNER LINER OF THE SHEATH SHOWED SIGNS OF SEPARATION FROM THE INNER DIAMETER. 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 6566321 ↗