Performer G10678Recalls & 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 Check-Flo Performer introducer is a tube used to help place catheters. Reports mostly describe blood or fluid leaking from the introducer, often at the diaphragm seal. There are 25 reports naming its identifier, with no deaths and 1 injury. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00827002106789), received between Dec 27, 2017 and Nov 12, 2019 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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.
Most reported problems
Device problems
- Fluid/Blood Leak24
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient12
- No Code Available1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9311070 ↗MalfunctionNov 4, 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: No Consequences Or Impact To Patient
MAUDE report 9272467 ↗MalfunctionMay 6, 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: No Consequences Or Impact To Patient
MAUDE report 8583118 ↗MalfunctionJan 16, 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: No Consequences Or Impact To Patient
MAUDE report 8252549 ↗MalfunctionJan 16, 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: No Consequences Or Impact To Patient
MAUDE report 8252546 ↗MalfunctionJan 16, 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: No Consequences Or Impact To Patient
MAUDE report 8252522 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE DIAPHRAGM. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. PATIENT DEMOGRAPHICS, HISTORY, AND FURTHER EVENT DETAILS ARE NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8213858 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE DIAPHRAGM. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. PATIENT DEMOGRAPHICS, HISTORY, AND FURTHER EVENT DETAILS ARE NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8213829 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE DIAPHRAGM. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. PATIENT DEMOGRAPHICS, HISTORY, AND FURTHER EVENT DETAILS ARE NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8213770 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE DIAPHRAGM. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. PATIENT DEMOGRAPHICS, HISTORY, AND FURTHER EVENT DETAILS ARE NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8213745 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE DIAPHRAGM. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. PATIENT DEMOGRAPHICS, HISTORY, AND FURTHER EVENT DETAILS ARE NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8213721 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A TOTAL OF FOUR PERFORMER INTRODUCERS FROM THIS SAME LOT LEAKED FROM THE DIAPHRAGM ON SEPARATE OCCASIONS. REPORTEDLY, THREE EVENTS OF LEAKING OCCURRED DURING "ARTERIOVENOUS FISTULA AND OR GRAFT" THROMBECTOMIES. THE FOURTH LEAKING EVENT OCCURRED DURING TESTING OF THE PERFORMER INTRODUCER PRIOR TO PATIENT CONTACT. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. THIS REPORT IS FOR ONE PERFORMER INTRODUCER WHICH LEAKED PRIOR TO PATIENT CONTACT. PLEASE SEE THE FOLLOWING MEDWATCH REPORTS FOR THE THREE OTHER EVENTS: 1820334-2018-03769, 1820334-2018-03770, 1820334-2018-03771.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8173809 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A TOTAL OF FOUR PERFORMER INTRODUCERS FROM THIS SAME LOT LEAKED FROM THE DIAPHRAGM ON SEPARATE OCCASIONS. REPORTEDLY, THREE EVENTS OF LEAKING OCCURRED DURING "ARTERIOVENOUS FISTULA AND OR GRAFT" THROMBECTOMIES. IN THESE THREE EVENTS A 0.035 J-WIRE WAS IN PLACE INSIDE THE COMPLAINT DEVICE AT THE TIME. ESTIMATED BLOOD LOSS WAS DESCRIBED AS "MINIMAL". NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. PATIENT'S OUTCOME WAS DESCRIBED AS "FINE". THE FOURTH LEAKING EVENT OCCURRED DURING TESTING OF THE PERFORMER INTRODUCER PRIOR TO PATIENT CONTACT. THIS REPORT IS FOR ONE PERFORMER INTRODUCER WHICH LEAKED DURING THE PROCEDURE. PLEASE SEE THE FOLLOWING MEDWATCH REPORTS FOR THE THREE OTHER EVENTS: 1820334-2018-03769; 1820334-2018-03770; 1820334-2018-03772.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8173774 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A TOTAL OF FOUR PERFORMER INTRODUCERS FROM THIS SAME LOT LEAKED FROM THE DIAPHRAGM ON SEPARATE OCCASIONS. REPORTEDLY, THREE EVENTS OF LEAKING OCCURRED DURING "ARTERIOVENOUS FISTULA AND OR GRAFT" THROMBECTOMIES. IN THESE THREE EVENTS A 0.035 J-WIRE WAS IN PLACE INSIDE THE COMPLAINT DEVICE AT THE TIME. ESTIMATED BLOOD LOSS WAS DESCRIBED AS "MINIMAL". NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. PATIENT'S OUTCOME WAS DESCRIBED AS "FINE". THE FOURTH LEAKING EVENT OCCURRED DURING TESTING OF THE PERFORMER INTRODUCER PRIOR TO PATIENT CONTACT. THIS REPORT IS FOR ONE PERFORMER INTRODUCER WHICH LEAKED DURING THE PROCEDURE. PLEASE SEE THE FOLLOWING MEDWATCH REPORTS FOR THE THREE OTHER EVENTS: 1820334-2018-03769, 1820334-2018-03771, 1820334-2018-03772.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8173743 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A TOTAL OF FOUR PERFORMER INTRODUCERS FROM THIS SAME LOT LEAKED FROM THE DIAPHRAGM ON SEPARATE OCCASIONS. REPORTEDLY, THREE EVENTS OF LEAKING OCCURRED DURING "ARTERIOVENOUS FISTULA AND OR GRAFT" THROMBECTOMIES. IN THESE THREE EVENTS A 0.035 J-WIRE WAS IN PLACE INSIDE THE COMPLAINT DEVICE AT THE TIME. ESTIMATED BLOOD LOSS WAS DESCRIBED AS "MINIMAL". NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. PATIENT'S OUTCOME WAS DESCRIBED AS "FINE". THE FOURTH LEAKING EVENT OCCURRED DURING TESTING OF THE PERFORMER INTRODUCER PRIOR TO PATIENT CONTACT. THIS REPORT IS FOR ONE PERFORMER INTRODUCER WHICH LEAKED DURING THE PROCEDURE. PLEASE SEE THE FOLLOWING MEDWATCH REPORTS FOR THE THREE OTHER EVENTS: 1820334-2018-03770; 1820334-2018-03771; 1820334-2018-03772.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8173736 ↗MalfunctionDec 14, 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 Consequences Or Impact To Patient
MAUDE report 8164659 ↗MalfunctionNov 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, DURING A FISTULOGRAM WITH BALLOON INTERVENTION PROCEDURE THE VALVES OF TWO PERFORMER INTRODUCER DEVICES LEAKED. ACCORDING TO THE INITIAL REPORTER, THE COMPLAINT DEVICES WERE PLACED IN THE UNSPECIFIED FISTULA AND A COOK "0.035" PTA BALLOON" DEVICE WAS USED IN CONJUNCTION. HOWEVER, AFTER PLACEMENT OF THE DEVICES, "BACK BLEEDING," OR BLOOD LEAKAGE THROUGH THE VALVE WAS OBSERVED. IT WAS REPORTED THAT THE BLOOD LOSS WAS APPROXIMATELY FIFTEEN (15) CC, NOT NECESSITATING ANY ADDITIONAL MEDICAL INTERVENTION. IT WAS UNKNOWN IF THE PATIENT'S ANATOMY WAS TORTUROUS OR CALCIFIED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS FINE WITH NO COMPLICATIONS. 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 8063691 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906786 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906688 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906687 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906686 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906560 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906544 ↗MalfunctionSep 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THE PHYSICIAN NOTED BLOOD LOSS AT THE DIAPHRAGM VALVE OF THE PERFORMER INTRODUCER DURING A FISTULOGRAM PROCEDURE. ESTIMATED BLOOD LOSS WAS REPORTEDLY 2ML THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW DEVICE. 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 7906502 ↗InjuryDec 27, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING ARTERIAL ACCESS FOR A FISTULA CASE, A 7 FR PERFORMER INTRODUCER SHEATH WAS BEING UTILIZED. INSERTION OVER THE GUIDE WIRE WAS PERFORMED, AND THE INNER DILATOR WAS REMOVED. THE SHEATH VALVE IMMEDIATELY BEGAN TO LEAK BLOOD, AND HAD TO BE EXCHANGED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT WAS NOTED THAT AN ADDITIONAL PROCEDURE WAS REQUIRED TO BE PERFORMED DUE TO THIS EVENT. INFORMATION REGARDING THE ADDITIONAL PROCEDURE, EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7149593 ↗
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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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