FlexorRecalls & reported problems across all models
Cook Incorporated · 134 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Flexor model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,437
- Deaths reported
- 7
- Injuries reported
- 315
- Recalls
- 3
We found 134 models of Flexor by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 1,437 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2014 and Sep 30, 2026 — classified as 7 deaths, 315 injuries, 1,114 malfunctions.
The most frequently reported specific device problem is “Material Separation” (456 reports).
3 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Flexor recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 26, 2025Open, Classified
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Z-0993-2026 · Root cause: Process control · names 17 of these models · Recall details · FDA record ↗
- Nov 12, 2021Terminated
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Z-0388-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 12, 2021Terminated
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Z-0387-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported Flexor problems
Device problems
- Material Separation456
- Detachment of Device or Device Component276
- Unraveled Material155
- Break151
- Fluid/Blood Leak104
- Peeled/Delaminated57
- Material Split, Cut or Torn50
- Leak/Splash42
Patient problems
- No Clinical Signs, Symptoms or Conditions452
- No Known Impact Or Consequence To Patient363
- No Consequences Or Impact To Patient259
- No Code Available164
- No Patient Involvement78
- Foreign Body In Patient63
- Insufficient Information38
- Device Embedded In Tissue or Plaque32
Flexor models
134 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Flexor G44154INTRODUCER, CATHETER1 recall1 death73 reports
- Flexor G44155INTRODUCER, CATHETER1 recall37 reports
- Flexor G47701INTRODUCER, CATHETER1 recall37 reports
- Flexor G11638INTRODUCER, CATHETER65 reports
- Flexor G56231INTRODUCER, CATHETER65 reports
- Flexor G29982INTRODUCER, CATHETER62 reports
- Flexor G56279INTRODUCER, CATHETER1 recall12 reports
- Flexor G13081INTRODUCER, CATHETER1 recall9 reports
- Flexor G32233INTRODUCER, CATHETER1 recall7 reports
- Flexor G36393INTRODUCER, CATHETER1 recall4 reports
- Flexor G12266INTRODUCER, CATHETER1 death53 reports
- Flexor G12606INTRODUCER, CATHETER1 recall3 reports
- Flexor G13033INTRODUCER, CATHETER1 recall3 reports
- Flexor G32373INTRODUCER, CATHETER1 recall3 reports
- Flexor G49101INTRODUCER, CATHETER1 recall3 reports
- Flexor G13160INTRODUCER, CATHETER1 recall2 reports
- Flexor G09442INTRODUCER, CATHETER1 recall1 report
- Flexor G13032INTRODUCER, CATHETER1 recall1 report
- Flexor G47700INTRODUCER, CATHETER1 recall1 report
- Flexor G49487INTRODUCER, CATHETER1 recall1 report
- Flexor G56278INTRODUCER, CATHETER1 recall1 report
- Flexor G13031INTRODUCER, CATHETER1 recall0 reports
- Flexor G49102INTRODUCER, CATHETER1 recall0 reports
- Flexor G13009INTRODUCER, CATHETER45 reports
- Flexor G10383INTRODUCER, CATHETER44 reports
- Flexor G56236INTRODUCER, CATHETER41 reports
- Flexor G11636INTRODUCER, CATHETER39 reports
- Flexor G11633INTRODUCER, CATHETER2 deaths33 reports
- Flexor G29983INTRODUCER, CATHETER30 reports
- Flexor G56232INTRODUCER, CATHETER28 reports
- Flexor G44153INTRODUCER, CATHETER26 reports
- Flexor G31138INTRODUCER, CATHETER1 death24 reports
- Flexor G11635INTRODUCER, CATHETER23 reports
- Flexor G13264INTRODUCER, CATHETER23 reports
- Flexor G29981INTRODUCER, CATHETER22 reports
- Flexor G10385INTRODUCER, CATHETER1 death19 reports
- Flexor G12242INTRODUCER, CATHETER19 reports
- Flexor G29996INTRODUCER, CATHETER19 reports
- Flexor G56221INTRODUCER, CATHETER19 reports
- Flexor G13091INTRODUCER, CATHETER18 reports
- Flexor G29985INTRODUCER, CATHETER18 reports
- Flexor G29999INTRODUCER, CATHETER18 reports
- Flexor G49045INTRODUCER, CATHETER18 reports
- Flexor G10384INTRODUCER, CATHETER16 reports
- Flexor G11637INTRODUCER, CATHETER16 reports
- Flexor G30009INTRODUCER, CATHETER16 reports
- Flexor G09908INTRODUCER, CATHETER15 reports
- Flexor G13069INTRODUCER, CATHETER15 reports
- Flexor G48189INTRODUCER, CATHETER15 reports
- Flexor G12836INTRODUCER, CATHETER14 reports
- Flexor G32224INTRODUCER, CATHETER14 reports
- Flexor G29986INTRODUCER, CATHETER13 reports
- Flexor G29989INTRODUCER, CATHETER13 reports
- Flexor G48187INTRODUCER, CATHETER13 reports
- Flexor G13539INTRODUCER, CATHETER11 reports
- Flexor G34880endoscopic access overtube, gastroenterology-urology11 reports
- Flexor G49043INTRODUCER, CATHETER10 reports
- Flexor G56220INTRODUCER, CATHETER1 death9 reports
- Flexor G56228INTRODUCER, CATHETER9 reports
- Flexor G09809INTRODUCER, CATHETER8 reports
- Flexor G09601INTRODUCER, CATHETER7 reports
- Flexor G12835INTRODUCER, CATHETER7 reports
- Flexor G48186INTRODUCER, CATHETER7 reports
- Flexor G49099INTRODUCER, CATHETER7 reports
- Flexor G49100INTRODUCER, CATHETER7 reports
- Flexor G50141INTRODUCER, CATHETER7 reports
- Flexor G56233INTRODUCER, CATHETER7 reports
- Flexor G08867INTRODUCER, CATHETER6 reports
- Flexor G11634INTRODUCER, CATHETER6 reports
- Flexor G11897INTRODUCER, CATHETER6 reports
- Flexor G29988INTRODUCER, CATHETER6 reports
- Flexor G32194INTRODUCER, CATHETER6 reports
- Flexor G46168endoscopic access overtube, gastroenterology-urology6 reports
- Flexor G56222INTRODUCER, CATHETER6 reports
- Flexor G56230INTRODUCER, CATHETER6 reports
- Flexor G08246INTRODUCER, CATHETER5 reports
- Flexor G09810INTRODUCER, CATHETER5 reports
- Flexor G10634INTRODUCER, CATHETER5 reports
- Flexor G19168endoscopic access overtube, gastroenterology-urology5 reports
- Flexor G30117INTRODUCER, CATHETER5 reports
- Flexor G35603INTRODUCER, CATHETER5 reports
- Flexor G48194INTRODUCER, CATHETER5 reports
- Flexor G49570INTRODUCER, CATHETER5 reports
- Flexor G56226INTRODUCER, CATHETER5 reports
- Flexor G29995INTRODUCER, CATHETER4 reports
- Flexor G29997INTRODUCER, CATHETER4 reports
- Flexor G30000INTRODUCER, CATHETER4 reports
- Flexor G35604INTRODUCER, CATHETER4 reports
- Flexor G48192INTRODUCER, CATHETER4 reports
- Flexor G56223INTRODUCER, CATHETER4 reports
- Flexor G07878INTRODUCER, CATHETER3 reports
- Flexor G09602INTRODUCER, CATHETER3 reports
- Flexor G12656INTRODUCER, CATHETER3 reports
- Flexor G12660INTRODUCER, CATHETER3 reports
- Flexor G13338INTRODUCER, CATHETER3 reports
- Flexor G19174endoscopic access overtube, gastroenterology-urology3 reports
- Flexor G32216INTRODUCER, CATHETER3 reports
- Flexor G34879endoscopic access overtube, gastroenterology-urology3 reports
- Flexor G35598INTRODUCER, CATHETER3 reports
- Flexor G46167endoscopic access overtube, gastroenterology-urology3 reports
Recent Flexor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: Insufficient Information
MAUDE report 50951556 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
As reported, upon insertion of the device during an unknown procedure, a FLEXOR BALKIN GUIDING SHEATH leaked fluid from the valve. A photo provided by the customer shows separation of the hub and separation of the side-arm tubing. Contralateral access was obtained in the femoral artery. The access site was not scarred or calcified, and the anatomy was not stenosed, calcified, or tortuous. The bifurcation was not steep or calcified. No other devices were used through the sheath during the procedure. Resistance was not encountered during insertion/advancement or removal of the sheath. The leak, hub separation, and side-arm separation occurred during the ¿insertion stage¿. The device was not pulled by the side-arm during the procedure. Another device of the same type, from a different lot, was used to 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947305 ↗MalfunctionSep 30, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946883 ↗InjurySep 30, 2026Break
As reported, during an angiogram of the right leg, a FLEXOR RAABE GUIDING SHEATH separated. Per the reporter, while pulling the sheath out of the patient, the sheath's hub separated and then the sheath unraveled and "broke" in the middle, becoming stuck in the patient's groin. The dilator was not reinserted prior to attempted removal of the sheath. Reportedly, the user was able to retrieve the broken parts of the sheath, which added approximately one hour to the procedure.A section of the device did not remain inside the patient¿s body. According to the initial reporter, the patient did not experience any adverse effects due to this event.Additional information has been requested but is not available at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945260 ↗MalfunctionJul 6, 2026Detachment of Device or Device Component
AS REPORTED, DURING A PROCEDURE INVOLVING INTERVENTION OF THE RIGHT LEG VIA CONTRALATERAL ACCESS IN THE LEFT GROIN, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED. PER THE REPORTER, AS THE SHEATH WAS REMOVED FROM THE LEFT GROIN, OVER A WIRE GUIDE AND ¿UP AND OVER¿, THE CHECK-FLO VALVE CAME OFF. THE DILATOR AND GUIDEWIRE WERE IN THE LUMEN OF THE SHEATH WHEN THE SEPARATION OCCURRED. THE SHEATH HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT. THE ACCESS SITE WAS "NORMAL", THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS. THE BIFURCATION WAS ACUTE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE SHEATH OR DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE SHEATH. ANOTHER MANUFACTURER'S LASER AND BALLOON WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. 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 25722288 ↗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 ↗MalfunctionJun 19, 2026Contamination /Decontamination Problem
AS REPORTED, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN A FLEXOR ANSEL GUIDING SHEATH¿S PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563430 ↗MalfunctionJun 8, 2026Detachment of Device or Device Component
AS REPORTED, DURING A THROMBECTOMY FOR TREATMENT OF A DEEP VEIN THROMBOSIS IN THE LEFT LEG, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED FROM THE DEVICE AS THE USER ATTEMPTED TO UNLOCK IT FROM A FEMALE LUER LOCK CONNECTING TUBE. ACCESS WAS OBTAINED IN THE POPLITEAL VEIN, AND THE ACCESS SITE WAS NORMAL. THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS, AND RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE SHEATH. NO OTHER DEVICES WERE USED THROUGH THE SHEATH. THE SHEATH WAS REMOVED, AND A NEW SHUTTLE SHEATH WAS USED TO COMPLETE THE PROCEDURE. 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 25427599 ↗MalfunctionJun 2, 2026Fluid/Blood Leak
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH LEAKED AS THE DEVICE WAS FLUSHED WITH SALINE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A LEAK FROM THE STOPCOCK. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE THE STOPCOCK WAS RECEIVED SEPARATED FROM THE EXTENSION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25359918 ↗MalfunctionMay 14, 2026Peeled/Delaminated
IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, THE INSIDE OF THE SHEATH OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS SHEATH PEELED OFF. IT WAS REPORTED, THERE WERE "INSIDE PIECES OF THE SHEATH" THAT SEPARATED INSIDE OF THE PATIENT AND THE PIECES WERE FLUSHED OUT AND ALSO REMOVED WITH A GRABBER. NO PART OF THE SHEATH WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHEATH. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175800 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED LOWER EXTREMITY PROCEDURE VIA ACCESS IN THE RIGHT BRACHIAL ARTERY, A FLEXOR RAABE GUIDING SHEATH LEAKED. AFTER INSERTION OF THE SHEATH, THE ¿LOCKING BUCKLE AT THE CONNECTION BETWEEN THE SHEATH EXTENSION TUBE AND THE MAIN SHEATH BODY¿ DETACHED, RESULTING IN INTRAOPERATIVE BLEEDING. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS. PER THE REPORTER, THE CLEAR SIDE-ARM TUBING DID NOT SEPARATE FROM THE HUB. THE SHEATH TUBING DID NOT SEPARATE FROM THE HUB. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION AND/OR ADVANCEMENT OF THE SHEATH NOR DURING INSERTION/ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS IN PLACE AT THE TIME OF THE EVENT. THE SHEATH, WHICH WAS REMOVED IMMEDIATELY, WAS REPLACED WITH ANOTHER VASCULAR 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 25151653 ↗MalfunctionMay 12, 2026Leak/Splash
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH LEAKED FROM THE VALVE. AFTER THE SHEATH WAS INITIALLY INSERTED INTO THE PATIENT, THE USER REMOVED THE DILATOR, AT WHICH POINT THE VALVE LEAKED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED. 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 25147283 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
AS REPORTED, DURING AN ANGIOGRAM, THE SIDE-ARM SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH¿S HUB. A STIFFENED MICROPUNCTURE DEVICE WAS USED TO OBTAIN ACCESS IN THE FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL, POPLITEAL, AND POSTERIOR TIBIAL ARTERIES. THE VESSELS WERE DESCRIBED AS ¿THREADY OR RATTY¿ AND CALCIFIED. ANOTHER MANUFACTURER¿S GUIDE WIRE AND CATHETER WERE USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER AND WIRE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF THE EVENT. BECAUSE THE PROCEDURE WAS ALMOST OVER, THE USER RECONNECTED THE SIDE-ARM AND HELD IT IN PLACE TO INJECT CONTRAST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828900 ↗MalfunctionApr 6, 2026Unsealed Device Packaging
IT WAS REPORTED THE TYVEK PACKAGING OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS WAS NOT SEALED. AN IMAGE WAS PROVIDED APPEARED TO SHOW AN UNSEALED PACKAGE. AS REPORTED, NO OTHER ADVERSE EFFECTS WERE REPORTED AS THE EVENT OCCURRED AT THE DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793646 ↗MalfunctionMar 26, 2026Break
AS REPORTED, DURING A PROCEDURE INVOLVING BALLOON ANGIOPLASTY OF THE TIBIAL ARTERY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT THE HUB UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT WAS HEPARINIZED AND CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN. THE ANATOMY, INCLUDING THE ACCESS SITE AND THE AORTIC BIFURCATION, WAS CALCIFIED. MINIMAL RESISTANCE WAS ENCOUNTERED UPON INSERTION/ADVANCEMENT OF THE SHEATH AND DURING INSERTION/ADVANCEMENT OF OTHER DEVICES THROUGH THE SHEATH. PER THE REPORTER, HALF-WAY THROUGH THE CASE, WHILE ATTEMPTING TO RETRACT THE SHEATH A ¿SHORT DISTANCE¿ BY PULLING THE SHEATH BY THE HUB, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE SHEATH BROKE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL. ANOTHER MANUFACTURER¿S 5-MILLIMETER BALLOON CATHETER WAS IN THE SHEATH LUMEN AT THE TIME OF THE EVENT. THE COMPLAINT DEVICE WAS EXCHANGED FOR A 5-FRENCH COOK FLEXOR ANSEL 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS SEPARATED JUST BELOW THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705748 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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