Performer G27242Recalls & reported problems
Cook Incorporated · Check-Flo Performer Introducer Set · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002272422), received between Aug 24, 2018 and Aug 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Sep 16, 2024Open, Classified
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Z-0045-2025 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED, A PERFORMER INTRODUCER WAS FOUND TO HAVE INCORRECT MARKINGS DURING AN INVENTORY CHECK. THE 5FR (FRENCH) SHEATH HAD THE APPROPRIATE GREY BAND MARKING WHILE THE 0.035 WIRE HAD RED MARKERS INSTEAD OF PURPLE. THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7814149 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.