Performer G09380Recalls & reported problems
Cook Incorporated · Check-Flo Performer, Introducer · Class 2
All models of Performer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002093805), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
Device problems
- Fluid/Blood Leak1
- Unintended Ejection1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2017Unintended Ejection; Fluid/Blood Leak
IT WAS REPORTED DURING THE PATIENT'S ANGIOGRAM PROCEDURE, WHILE PREPARING TO PERFORM A RUN, CONTRAST SPRAYED BACK (FROM BACK END) AT THE USERS. THIS OCCURRED TWICE. THE CUSTOMER INDICATED THAT AT BOTH OCCURRENCES ANOTHER MANUFACTURER'S BALLOON WAS IN THE SHEATH. IT WAS ALSO NOTED THAT DURING THE PROCEDURE ANOTHER MANUFACTURER'S LASER WAS USED. THE FACILITY WAS ABLE TO COMPLETE THE PROCEDURE WITH THE COMPLAINT DEVICE. ADDITIONAL INFORMATION PROVIDED IDENTIFIED THE DEVICE WAS IN THE PATIENT AT THE TIME OF THE INCIDENT.
Patient problems: Chemical Exposure
MAUDE report 6931646 ↗
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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 14, 2026 · each report above links to its original FDA record
- 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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