Performer G11936Recalls & 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 00827002119369), received between Jan 27, 2022 and Jan 27, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
- Material Separation1
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.
MalfunctionJan 27, 2022Material Puncture/Hole; Material Separation; Material Puncture/Hole; Material Separation
AS REPORTED, DURING PREPARATION OF THE DEVICE PRIOR TO USE, THE DILATOR INCLUDED IN A PERFORMER CHB GUIDING SHEATH APPEARED TO PERFORATE THE SHEATH UPON INSERTION OF THE DILATOR INTO THE SHEATH. A NEW DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE UNKNOWN PROCEDURE. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE DILATOR WAS NOTED TO EXIT THE SHEATH HUB ALONGSIDE THE SHEATH. THE SHEATH MATERIAL WAS NOT NOTED TO BE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367836 ↗
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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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