Performer G08139Recalls & 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 00827002081390), received between Jul 3, 2017 and Sep 22, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2025Detachment 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 Clinical Signs, Symptoms or Conditions
MAUDE report 23116064 ↗MalfunctionJul 3, 2017Torn Material; Torn Material
IT WAS REPORTED THAT A PERFORMER INTRODUCER WAS USED DURING AN UNSPECIFIED PROCEDURE. WHEN THIS PRODUCT WAS USED WITH A COMPETITOR'S DEVICE, THE WIRE CUT THROUGH THE TIP X 1CM, THE WIRE BECAME CAUGHT AND THUS UNRAVELED AND WAS VERY DIFFICULT TO REMOVE. ADDITIONAL INFORMATION WAS REQUESTED INCLUDING PATIENT OUTCOME AND NOT YET RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6684489 ↗
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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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