Check-FloRecalls & reported problems across all models
Cook Incorporated · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Check-Flo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 1
We found 19 models of Check-Flo by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2014 and Sep 30, 2026 — classified as 22 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (25 reports).
1 FDA recall record 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
Check-Flo 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.
- Apr 17, 2025Open, Classified
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Z-1786-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Check-Flo problems
Device problems
- Fluid/Blood Leak25
- Detachment of Device or Device Component12
- Leak/Splash11
- Material Separation11
- Difficult to Remove7
- Material Split, Cut or Torn7
- Break5
- Device Contamination with Chemical or Other Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Known Impact Or Consequence To Patient27
- No Consequences Or Impact To Patient19
- Blood Loss12
- No Patient Involvement8
- Hemorrhage/Blood Loss/Bleeding5
- Foreign Body In Patient4
- No Code Available4
Check-Flo models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Check-Flo G08686INTRODUCER, CATHETER1 recall2 reports
- Check-Flo G11672INTRODUCER, CATHETER29 reports
- Check-Flo G08024INTRODUCER, CATHETER28 reports
- Check-Flo G28999INTRODUCER, CATHETER10 reports
- Check-Flo G07369INTRODUCER, CATHETER5 reports
- Check-Flo G12423INTRODUCER, CATHETER5 reports
- Check-Flo G07417INTRODUCER, CATHETER4 reports
- Check-Flo G08955INTRODUCER, CATHETER4 reports
- Check-Flo G12830INTRODUCER, CATHETER4 reports
- Check-Flo G12831INTRODUCER, CATHETER4 reports
- Check-Flo G15476Endoscope channel accessory4 reports
- Check-Flo G10025INTRODUCER, CATHETER3 reports
- Check-Flo G28327INTRODUCER, CATHETER2 reports
- Check-Flo G07493INTRODUCER, CATHETER1 report
- Check-Flo G07564INTRODUCER, CATHETER1 report
- Check-Flo G07600INTRODUCER, CATHETER1 report
- Check-Flo G09256INTRODUCER, CATHETER1 report
- Check-Flo G12896INTRODUCER, CATHETER1 report
- Check-Flo G28434INTRODUCER, CATHETER1 report
Recent Check-Flo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949915 ↗MalfunctionMar 31, 2026Material Split, Cut or Torn
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER ACCORDIONED/DEVELOPED A SMALL TEAR ¿DURING EXCHANGES¿. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A POSSIBLE SMALL TEAR AT THE TIP OF THE SHEATH. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 24746605 ↗MalfunctionDec 11, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED 03MAR2026. THE DEVICE WAS USED AS A TROCAR THROUGH THE UTERINE WALL, THROUGH WHICH NEONATAL AND PREMATURE LAPAROSCOPY INSTRUMENTS ARE HANDLED. THERE WERE NO ISSUES ENCOUNTERED DURING SHEATH INSERTION; HOWEVER, INSTRUMENTS WERE DIFFICULT TO MOBILIZE IN THE ¿DUCT¿, AND THE DEVICE WAS ¿TOO STRONG¿ TO MOBILIZE INSTRUMENTS CORRECTLY. A ¿NSP¿ WIRE WAS USED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777997 ↗MalfunctionAug 13, 2025Complete Blockage; Difficult to Remove; Complete Blockage; Difficult to Remove
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 22797650 ↗MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A "STANDARD ILIAC PROCEDURE", A PERFORMER INTRODUCER LEAKED, CAUSING THE PATIENT TO LOSE "SLIGHTLY MORE BLOOD THAN NORMAL". THE PROCEDURE WAS COMPLETED NORMALLY, WITHOUT DISADVANTAGE FOR THE PATIENT. 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. ANOTHER PERFORMER INTRODUCER ALSO LEAKED DURING THE PROCEDURE. THIS DEVICE WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532604 ↗InjuryJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
COOK WAS NOTIFIED THAT EXCESSIVE VALVE LEAKAGE FROM THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER OCCURRED DURING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER WAS USED TO SUPPORT SHEATH PLACEMENT THROUGH FENESTRATIONS OF A PRE-IMPLANTED EVAR DEVICE. A COOK SALES REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE. DURING THE PROCEDURE: THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER WAS INSERTED OVER A COOK LUNDERQUIST WIRE AND POSITIONED FOR COOK ANSEL SHEATH INSERTION. THE VALVE WAS PUNCTURED TWICE FOR STANDARD FENESTRATED ACCESS. TWO 7F SHEATHS (COOK ANSEL AND A COMPETITOR'S SHEATH) WERE INTRODUCED THROUGH THE 20F COOK CHECK-FLOW EXTRA LARGE INTRODUCER. UPON POSITIONING, PROFUSE VALVE LEAKAGE WAS OBSERVED. THE ANESTHETIC TEAM ADMINISTERED FLUIDS URGENTLY IN RESPONSE TO DROPPING BLOOD PRESSURE. DESPITE EFFORTS TO MITIGATE LOSS, THE PATIENT REQUIRED BLOOD TRANSFUSION PRODUCTS. A PRESSURE BAG WITH HEPARINIZED SALINE WAS CONNECTED TO THE SIDE PORT TO LIMIT BLOOD LOSS. IT WAS ESTIMATED THAT OVER 2 LITERS OF BLOOD WERE LOST. A DECISION WAS MADE TO DEPLOY THE COMPETITOR'S FLARED STENTS AND THE CUSTOM-MADE FENESTRATED DEVICE. HOWEVER, THE LEFT
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22475120 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A PULSE FIELD ABLATION PROCEDURE, THE HUB OF A PERFORMER INTRODUCER¿S DILATOR SEPARATED UPON ADVANCEMENT OF THE DEVICE INTO THE FEMORAL VEIN OVER AN UNSPECIFIED WIRE GUIDE. 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 22341650 ↗InjuryJun 12, 2025Difficult to Remove; Difficult to Remove
AS REPORTED, DURING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) THAT REQUIRED MECHANICAL CIRCULATORY SUPPORT, ANOTHER MANUFACTURER¿S 17-FRENCH CATHETER WAS DIFFICULT TO REMOVE FROM A PERFORMER INTRODUCER. PER THE REPORTER, THE FORCE USED WHILE TRYING TO DISLODGE THE CATHETER RESULTED IN DAMAGE TO ANOTHER MANUFACTURER¿S SUTURES AND EXCESSIVE BLEEDING THAT REQUIRED PLACEMENT OF A ¿STUNT¿ (ASSUMED TO BE A STENT).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22193028 ↗MalfunctionJun 11, 2025Difficult to Remove; Difficult to Remove
AS REPORTED, DURING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) THAT REQUIRED MECHANICAL CIRCULATORY SUPPORT, ANOTHER MANUFACTURER¿S 17-FRENCH CATHETER WAS DIFFICULT TO REMOVE FROM A PERFORMER INTRODUCER. PER THE REPORTER, THE CATHETER BECAME STUCK AND DUE TO EXCESSIVE FORCE, THE CATHETER BROKE OFF WITHIN THE COMPLAINT DEVICE, WHICH MADE CLOSURE WITH ANOTHER MANUFACTURER¿S DEVICE ¿EXTREMELY COMPLICATED.¿
Patient problems: Insufficient Information
MAUDE report 22188221 ↗MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB SEPARATED FROM A PERFORMER INTRODUCER. THE DEVICE WAS PLACED IN THE RIGHT FEMORAL ARTERY. AFTER ANOTHER MANUFACTURER¿S UNSPECIFIED STENT CATHETER (DESCRIBED AS A LARGE STENT FOR ILIAC BRANCH BLOOD VESSELS) WAS ADVANCED THROUGH THE SHEATH, THE HUB OF THE SHEATH SEPARATED AND LEAKED BLOOD. THE STENT CATHETER WAS IMMEDIATELY REMOVED. PER THE REPORTER, THE SEPARATED SHEATH SHAFT WENT ¿DEEP INTO THE SKIN SURFACE AND TISSUES¿; HOWEVER, THE SHAFT WAS REPORTEDLY REMOVED BY HAND. A NEW SHEATH OF THE SAME TYPE WAS PLACED, AND THE STENT WAS THEN DELIVERED OVER AN UNKNOWN WIRE GUIDE TO COMPLETE THE PROCEDURE NORMALLY. THE EVENT REPORTEDLY RESULTED IN PROLONGED PROCEDURE TIME AND INCREASED BLEEDING; HOWEVER, THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS. ADDITIONAL INFORMATION REPORTED THAT THE DAMAGE TO THE SHEATH OCCURRED DUE TO ¿CARELESS OPERATION BY THE USER¿ AND NOTED THAT THE CUSTOMER ACCIDENTALLY DAMAGED 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 21698956 ↗MalfunctionMar 13, 2025
THE PACKAGE IS LABELED AS A COOK 10F X30CM SHEATH. THE SCRUBBER NOTICED THAT THE ACTUAL SHEATH IS LABELED AS A 14F SHEATH. THIS DID NOT TOUCH THE PATIENT. THE SCRUBBER NOTICED IT AS HE WAS SETTING UP THE TABLE. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21592650 ↗MalfunctionFeb 20, 2025Unraveled Material; Unraveled Material
AS REPORTED, UPON OPENING THE PACKAGE PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE DISTAL END OF A PERFORMER INTRODUCER¿S WIRE WAS ELONGATED/UNRAVELED. THE WIRE DID NOT MAKE PATIENT CONTACT. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21424021 ↗MalfunctionJan 21, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
AS ORIGINALLY REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER'S DILATOR WOULD NOT FIT IN THE SHEATH. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 ON 16JAN2025, THE SILICONE DISC WAS DISLODGED IN THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200515 ↗MalfunctionDec 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, DURING INSPECTION UPON ARRIVAL WITHIN A DISTRIBUTION FACILITY, FOREIGN MATTER WAS FOUND INSIDE A PERFORMER INTRODUCER'S STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20877470 ↗MalfunctionNov 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE VIA ACCESS IN THE FEMORAL ARTERY, THE TIP OF A PERFORMER INTRODUCER WAS ¿DEFORMED¿, AND A WIRE GUIDE WOULD NOT PASS THROUGH IT. THE DEVICE PACKAGE WAS NOT DAMAGED, AND THE DEVICE WAS NOT SHARP. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. 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 ON (B)(6) 2024, THE DILATOR TIP WAS SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696495 ↗
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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