Check-Flo G11672Recalls & reported problems
Cook Incorporated · Check-Flo Performer Introducer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Medical Check-Flo Performer Introducer is a catheter used to guide wires and catheters into blood vessels during procedures. The 28 reports mostly describe leaking at the hub, parts separating or detaching, and material coming apart, with some catheters getting stuck and being hard to remove, and several reports of blood loss during procedures. Six injuries and no deaths were reported. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002116726), received between Aug 26, 2014 and Sep 30, 2026 — classified as 6 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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
- Fluid/Blood Leak8
- Detachment of Device or Device Component6
- Difficult to Remove4
- Material Separation4
- Device Contamination with Chemical or Other Material2
- Device Dislodged or Dislocated2
- Leak/Splash2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Blood Loss5
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- No Patient Involvement2
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 29 reports, 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 ↗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 ↗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 ↗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 ↗MalfunctionApr 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, PRIOR TO USE DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER WAS OPENED AND IT DID NOT HAVE A "VALVE". THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE SILICONE DISC WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19050310 ↗MalfunctionAug 16, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
AS REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR, A PERFORMER INTRODUCER LEAKED AT THE HUB. THE DEVICE WAS OPENED AND THE SHEATH WAS FLUSHED WITH SALINE. WHEN THE DILATOR WAS INSERTED INTO THE SHEATH, IT WOULD NOT ADVANCE; THEREFORE, THE PHYSICIAN USED FORCE TO PUSH THE DILATOR THROUGH THE SHEATH. THE SHEATH AND DILATOR WERE THEN SUCCESSFULLY INTRODUCED INTO THE LEFT FEMORAL ARTERY. WHEN THE DILATOR WAS REMOVED FROM THE SHEATH, THE HEMOSTATIC SHEATH VALVE LEAKED. THE PHYSICIAN THEN ATTEMPTED TO INTRODUCE ANOTHER MANUFACTURER'S STENT GRAFT INTO THE SHEATH; HOWEVER, IT WOULD NOT FIT IN THE SHEATH. THE SHEATH WAS REMOVED NORMALLY, AND ANOTHER SHEATH FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THE STENT GRAFT WAS INTRODUCED INTO THE REPLACEMENT SHEATH WITHOUT DIFFICULTY. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED. THE COMPLAINT SHEATH WAS IN PLACE LESS THAN FIVE MINUTES. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH. THE TIPS OF THE SHEATH AND DILATOR WERE NOT DAMAGED. VESSEL SPASMS DID NOT OCCUR. PER THE REPORTER, "SOME" BLOOD LOSS OCCURRED WHEN THE LARGE SHEATH WAS REMOVED; HOWEVER, THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557950 ↗MalfunctionMay 25, 2023Detachment 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 17004147 ↗MalfunctionFeb 17, 2023Detachment 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 16399075 ↗MalfunctionNov 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12813841 ↗MalfunctionJan 28, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
AS REPORTED, THERE WAS A WHITE POWDERY SUBSTANCE DISCOVERED WITHIN THE SEALED PACKAGES OF PERFORMER INTRODUCERS. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11243305 ↗MalfunctionJan 21, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11208168 ↗InjuryNov 17, 2020Fluid/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: Blood Loss
MAUDE report 10855260 ↗MalfunctionNov 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR FOR A JUXTARENAL ANEURYSM, A PERFORMER INTRODUCER LEAKED AT THE HUB. THE COMPLAINT DEVICE WAS INSERTED INTO THE LEFT COMMON ILIAC ARTERY TO ALLOW FOR INTRODUCTION OF TWO 7 FRENCH COOK SHEATHS, USED TO CANNULATE THE LEFT RENAL AND SUPERIOR MESENTERIC ARTERIES. WHEN THE SECOND 7 FRENCH SHEATH WAS INSERTED INTO THE PUNCTURED VALVE OF THE COMPLAINT DEVICE, BLOOD BEGAN TO LEAK PROFUSELY. THE SURGEON REPORTEDLY PUNCTURED THE VALVE LEAFLETS MULTIPLE TIMES OFF CENTER. EACH TIME THE SECOND 7 FRENCH SHEATH WAS INSERTED, BLOOD LOSS WAS "EVIDENT". THE USER REMOVED THE COMPLAINT DEVICE AND REPLACED IT WITH ANOTHER MANUFACTURER'S 16 FRENCH SHEATH TO STOP BLOOD LOSS. THE OTHER MANUFACTURER'S 16 FRENCH SHEATH WOULD ONLY ALLOW FOR INTRODUCTION OF 6 FRENCH SHEATHS AND BALLOON CATHETERS. REPORTEDLY, BECAUSE A 7 FRENCH SHEATH WAS NEEDED TO INTRODUCE A STENT INTO THE SMA, REMOVAL OF THE COMPLAINT DEVICE INCREASED THE COMPLEXITY OF THE CASE. THE PATIENT DID NOT REQUIRE ANY INTERVENTION FOR BLOOD LOSS. 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
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10853820 ↗MalfunctionFeb 26, 2020Difficult to Remove; 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 Consequences Or Impact To Patient
MAUDE report 9759107 ↗MalfunctionNov 15, 2019Difficult to Remove; 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 Consequences Or Impact To Patient
MAUDE report 9327537 ↗InjuryJul 2, 2019Fluid/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: Blood Loss; No Code Available
MAUDE report 8752868 ↗MalfunctionOct 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7993713 ↗MalfunctionJun 29, 2018Fluid/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 Known Impact Or Consequence To Patient
MAUDE report 7650134 ↗MalfunctionJun 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO INVESTIGATION FINDINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7650133 ↗MalfunctionFeb 27, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, THE PERFORMER INTRODUCER VALVE WAS LEAKING DURING INSERTION WHILE TESTING THE DEVICE. THE INTRODUCER DID NOT COME INTO CONTACT WITH THE PATIENT. 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 7300226 ↗MalfunctionSep 19, 2017Device Damaged Prior to Use; Device Damaged Prior to Use
A PERFORMER INTRODUCER WAS BEING PREPARED TO BE USED IN A THORASIC ENDOVASCULAR ANEURYSM REPAIR. UPON OPENING THE PACKAGE, THE PHYSICIAN OBSERVED THE TIP OF THE DILATOR TO BE DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6876395 ↗MalfunctionAug 3, 2017Bent; Split
IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, DILATOR TIP CURVED AND NARROWED. PER PHOTOGRAPHS OF THE DILATOR TIP, THE TIP ALSO EXHIBITED A SPLIT.
Patient problems: No Information
MAUDE report 6764525 ↗InjuryMay 23, 2016Material Separation; Material Separation
THE VALVE TORN APART FROM THE INTRODUCER WHILE ADMINISTERING THE CONTRAST MEDIA. THE USER FACILITY CHANGED THE INTRODUCER AND CONTINUED WITH THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5673173 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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