Performer G27025Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002270251), received between Jul 18, 2016 and Sep 17, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Contamination /Decontamination Problem1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED AT THE SIDE PORT. THE LEAK WAS OBSERVED AS THE NURSE FLUSHED THE DEVICE WITH SALINE DURING PREPARATION OF THE INTRODUCER. THE DEVICE DID NOT MAKE PATIENT CONTACT. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10545999 ↗MalfunctionMay 4, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Patient Involvement
MAUDE report 10020940 ↗InjuryJul 18, 2016Break; Break
DURING THE PROCEDURE THE CLINICIAN NOTICED THE END OF THE DILATOR WAS DAMAGED. THE PRODUCT WAS RETURNED. INVESTIGATORS DETERMINED THAT THE TIP HAD SEPARATED FROM THE DEVICE ON (B)(6) 2016. THE EVENT WAS MADE REPORTABLE ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5801983 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page