Performer G07605Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002076051), received between Aug 10, 2017 and Mar 30, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Kinked1
- Material Separation1
- Split1
- Sticking1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2019Detachment 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 Consequences Or Impact To Patient
MAUDE report 8467476 ↗MalfunctionJan 16, 2018Split; Split
IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE, THE PERFORMER INTRODUCER PACKAGE WAS OPENED AND THE TIP OF THE DILATOR WAS OBSERVED TO BE DAMAGED/ SPLIT. IT WAS NOTED THAT THERE WAS A SLIGHT EDGE ON THE TIP. ANOTHER INTRODUCER OF THE SAME LOT NUMBER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7193180 ↗MalfunctionAug 10, 2017Kinked; Material Separation; Sticking; Kinked; Material Separation; Sticking
A PERFORMER INTRODUCER WAS USED DURING AN ENDOVENOUS LASER ABLATION PROCEDURE. IT WAS REPORTED THAT WHEN WITHDRAWING, THE J WIRE, IT BECAME STUCK JUST DISTAL TO THE STOP FLOW END AND THE FLOPPY TIP FELL OFF. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, CHEST X-RAY (CXR) AND X-RAY OF THE LEG AT THE ENTRY SITE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6785828 ↗
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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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