Performer G12424Recalls & reported problems
Cook Incorporated · Micropuncture 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002124240), received between Sep 11, 2019 and Dec 30, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
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
- Fluid/Blood Leak4
- Leak/Splash1
- Unraveled Material1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
ADDITIONAL INFORMATION WAS RECEIVED 07JAN2021. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND THE DEVICE WAS ADVANCED TO THE LIVER. THE PATIENT DID NOT REQUIRE ANY INTERVENTION DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11094532 ↗MalfunctionOct 23, 2020Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10726080 ↗MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9641752 ↗MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 11FEB2020. THE LEAK OCCURRED AT THE CONNECTION BETWEEN THE SHAFT AND HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9641598 ↗MalfunctionSep 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8989543 ↗
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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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