Performer G07913Recalls & reported problems
Cook Incorporated · Check-Flo Performer, Introducer Set · Class 2
All models of Performer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002079137), received between Mar 15, 2019 and Mar 15, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Puncture/Hole2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER AND AGE WAS UNDERGOING A LEG ANGIOGRAPHY PROCEDURE UTILIZING A PERFORMER INTRODUCER FOR INITIAL ACCESS INTO THE COMMON FEMORAL ARTERY. THE DEVICE HAD BEEN IN PLACE APPROXIMATELY FIVE MINUTES WHEN THEY WITHDREW THE DILATOR AND NOTED THE WIRE HAD PUNCTURED THE DILATOR IN THE MIDSHAFT REGION. IT APPEARED THE DILATOR MATERIAL WAS VERY THIN. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8426231 ↗MalfunctionMar 15, 2019Material Puncture/Hole; Material Puncture/Hole
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 8426198 ↗
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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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