Performer G08308Recalls & 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
- 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 00827002083080), received between Jun 13, 2017 and Jan 23, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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
- Device Damaged Prior to Use1
- Kinked1
- Sharp Edges1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2019Sharp Edges; Sharp Edges
IT WAS REPORTED, A MALE CHILD OF UNKNOWN AGE WAS UNDERGOING AN UNKNOWN PROCEDURE, DATE NOT SPECIFIED. AT AN UNSPECIFIED POINT IN THE PROCEDURE IT WAS NOTED THE TIP OF THE PERFORMER MULLINS GUIDING SHEATH WAS TOO SHARP-EDGED. PATIENT ANATOMY WAS NOT CALCIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED. 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. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT INFORMATION HAS NOT BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8272234 ↗MalfunctionJun 13, 2017Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use
THE DILATOR TIP OF THE MULLIN SHEATH WAS FOUND DEFECTED WHEN TAKEN OUT FROM PACKAGING. ACCORDING TO THE REPORTER THE DILATOR TIP WAS KINKED AND THE EDGE APPEARED NOT AS SMOOTH AS THE NORMAL. NO PATIENT CONTACT WAS REPORTED REGARDING THE DEVICE.
Patient problems: No Information
MAUDE report 6638204 ↗
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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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