Performer G28445Recalls & reported problems
Cook Incorporated · Check-Flo Performer Introducer · Class 2
All models of Performer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002284456), received between May 22, 2019 and Mar 28, 2022 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
- Material Split, Cut or Torn1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2022Break; Break
AS REPORTED, WHEN FLUSHING THE DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE TIP OF A PERFORMER INTRODUCER DILATOR SEPARATED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934501 ↗MalfunctionFeb 1, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
AS REPORTED, DURING AN IVC FILTER RETRIEVAL PROCEDURE, A PERFORMER INTRODUCER SHEATH BROKE WHILE TRYING TO REMOVE THE FILTER. THE RETRIEVAL WAS NOTED THE BE DIFFICULT. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13419143 ↗MalfunctionMay 22, 2019Unsealed Device Packaging; Unsealed Device Packaging
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 8633946 ↗
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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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