Performer G07816Recalls & reported problems
Cook Incorporated · Check-Flo Performer, Introducer · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002078161), received between Oct 9, 2017 and May 22, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Break1
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Material Split, Cut or Torn1
- Split1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16977217 ↗MalfunctionMar 24, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A PERFORMER MULLINS GUIDING SHEATH WAS NOT OPENED OR USED BECAUSE A FOREIGN OBJECT WAS DETECTED INSIDE OF THE PRIMARY PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892664 ↗MalfunctionNov 27, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9383317 ↗MalfunctionSep 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8979187 ↗MalfunctionJan 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8236539 ↗MalfunctionOct 9, 2017Break; Split
IT WAS REPORTED THAT AFTER OPENING THE DEVICE PACKAGING, THE SHEATH WAS NOTED TO BE DAMAGED, IT WAS SPLIT 30.5CM FROM THE CHECK FLO VALVE AND EXTENDED THROUGH THE RADIOPAQUE TIP.
Patient problems: No Information
MAUDE report 6931204 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.