Performer G28433Recalls & 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 00827002284333), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (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 Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2023Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation
ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2023. FEMORAL ACCESS WAS OBTAINED FOR A CONTRALATERAL APPROACH DURING THE STANDARD ENDOVASCULAR REPAIR CASE. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH OR UPON INSERTION OR REMOVAL OF OTHER DEVICES THROUGH THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16701580 ↗
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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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