Performer G07337Recalls & reported problems
Cook Incorporated · Check-Flo Performer, Introducer Set · Class 2
All models of Performer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002073371), received between Oct 9, 2017 and Aug 13, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Contamination /Decontamination Problem1
- Difficult to Advance1
- Fluid/Blood Leak1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 21AUG2025. THE ACCESS SITE WAS COMMON FEMORAL ARTERY. THE WIRE GUIDE INCLUDED WITH THE COMPLAINT DEVICE WAS USED DURING THE PROCEDURE. NO DEVICE WAS USED THROUGH THE SHEATH BEFORE THE LEAKING WAS NOTED, ONLY CONTRAST. THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797954 ↗MalfunctionOct 14, 2021Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Difficult to Advance; Material Deformation; Material Split, Cut or Torn
UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP WAS NOTED TO BE SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631376 ↗MalfunctionJul 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, DURING INSPECTION AT A DISTRIBUTION FACILITY, AN UNIDENTIFIED PARTICLE WAS OBSERVED IN THE PRIMARY PACKAGE OF A PERFORMER INTRODUCER. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8768954 ↗MalfunctionOct 9, 2017Break
IT WAS REPORTED THAT THE INTRODUCER COULD NOT BE FLUSHED WITH HEPARINIZED SALINE. NO PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, AND THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.
Patient problems: Foreign Body In Patient
MAUDE report 6931689 ↗
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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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