Performer G08835Recalls & 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 00827002088351), received between Jan 20, 2022 and Jan 20, 2022 — classified as 1 malfunction.
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
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED PEDIATRIC HEART SURGERY INVOLVING PLACEMENT OF A STENT GRAFT, THE SIDE ARM OF A PERFORMER MULLINS GUIDING SHEATH CAME LOOSE FROM THE HUB AND LEAKED CONTRAST. CONTRAST WAS INJECTED WHEN THE STENT POSITION WAS CONTROLLED. BECAUSE OF THE POSITION OF THE STENT, THE SHEATH WAS NOT REPLACED. PER THE REPORTER, THE USER FIXED THE LEAK AND THE PROCEDURE WAS COMPLETED. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 13309026 ↗
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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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