Performer G13419Recalls & 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 00827002134195), received between Oct 30, 2018 and Oct 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2018Material Separation; Material Separation
IT WAS REPORTED DURING "MELODY VALVE PLACEMENT VIA RIGHT INTERNAL JUGULAR VEIN" PROCEDURE, TWO PERFORMER MULLINS GUIDING SHEATHS DISCONNECTED AT THE HUB. THE PROCEDURE INVOLVED A (B)(6) MALE WITH A HISTORY OF PULMONARY VALVE INSUFFICIENCY AND A PRIOR HISTORY OF MELODY VALVE PLACEMENT AND REPEATED RIGHT NECK ACCESS. ACCORDING TO THE INITIAL REPORTER, THE FIRST SHEATH (REFERENCE THIS REPORT) WAS ADVANCED OVER ANOTHER MANUFACTURER'S WIRE GUIDE AND, SOON AFTER, THE WHITE HUB ON THE DILATOR SEPARATED. THE COMPLAINT DEVICE WAS EXCHANGED FOR ANOTHER PERFORMER MULLINS GUIDING SHEATH (REFERENCE REPORT 1820334-2018-03181), AND THE HUB DISCONNECTED ON THIS DEVICE AS WELL. THE PATIENT WAS SAID TO HAVE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, NOTING THAT THERE WAS MORE BLOOD LOSS THAN USUAL; HOWEVER, NO TRANSFUSIONS WERE REQUIRED AS A RESULT. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL. 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 8019625 ↗
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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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