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Performer G27023Recalls & 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 00827002270237), received between Aug 8, 2017 and Oct 6, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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

  • Break2
  • Contamination /Decontamination Problem1
  • Detachment of Device or Device Component1
  • Device Contaminated During Manufacture or Shipping1
  • Device Dislodged or Dislocated1
  • Difficult to Advance1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Patient Involvement2
  • Insufficient Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 6, 2022Contamination /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 Clinical Signs, Symptoms or Conditions

    MAUDE report 15554812 ↗
  • MalfunctionAug 4, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

    AS REPORTED, THE DILATOR OF A PERFORMER INTRODUCER, WOULD NOT ADVANCE INTO THE SHEATH MORE THAN A FEW INCHES WITHOUT EXTREME FORCE. THE ISSUE WAS DISCOVERED WHILE THEY WERE PREPPING THE DEVICE FOR AN UNSPECIFIED PROCEDURE AND THE DEVICE WAS NOT USED. ANOTHER SAME TYPE DEVICE WAS USED WITH NO PROBLEMS. UPON INSPECTION OF THE RETURNED DEVICE IT WAS DISCOVERED THAT THE SILICON DISC (VALVE) WAS NOT IN THE CORRECT POSITION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15165464 ↗
  • MalfunctionFeb 9, 2022Break; Break

    AS REPORTED, A PERFORMER INTRODUCER'S TIP BROKE DURING AN UNKNOWN PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 13497212 ↗
  • MalfunctionMar 29, 2021Detachment 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 Clinical Signs, Symptoms or Conditions

    MAUDE report 11585852 ↗
  • MalfunctionSep 28, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    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 10592292 ↗
  • MalfunctionAug 8, 2017Break

    IT WAS REPORTED BY THE DISTRIBUTION CENTER THAT THE DEVICE WAS NOTED TO BE DAMAGED AND FELL APART. THE DISTRICT MANAGER NOTED IT APPEARED THAT THE SHEATH DILATOR WAS PUSHED, SEPARATING THE VALVE FROM THE SHEATH MATERIAL. THE DEVICE DID NOT HAVE ANY PATIENT CONTACT.

    Patient problems: No Patient Involvement

    MAUDE report 6774685 ↗

Other INTRODUCER, CATHETER devices

All INTRODUCER, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.