PerformerRecalls & reported problems across all models
Cook Incorporated · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Performer model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 289
- Deaths reported
- 3
- Injuries reported
- 27
- Recalls
- 2
We found 62 models of Performer by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 289 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2014 and Feb 24, 2026 — classified as 3 deaths, 27 injuries, 259 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (74 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Performer recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 17, 2025Open, Classified
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Z-1787-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Performer problems
Device problems
- Fluid/Blood Leak74
- Material Separation36
- Leak/Splash30
- Material Split, Cut or Torn24
- Detachment of Device or Device Component23
- Break20
- Contamination /Decontamination Problem15
- Device Dislodged or Dislocated12
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- No Known Impact Or Consequence To Patient78
- No Consequences Or Impact To Patient66
- No Patient Involvement32
- No Code Available15
- Blood Loss7
- Insufficient Information7
- Foreign Body In Patient4
Performer models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Performer G08957INTRODUCER, CATHETER1 recall3 deaths41 reports
- Performer G27242INTRODUCER, CATHETER1 recall1 report
- Performer G10678INTRODUCER, CATHETER25 reports
- Performer G09210INTRODUCER, CATHETER18 reports
- Performer G28322INTRODUCER, CATHETER16 reports
- Performer G10675INTRODUCER, CATHETER14 reports
- Performer G09691INTRODUCER, CATHETER13 reports
- Performer G28438INTRODUCER, CATHETER10 reports
- Performer G08133INTRODUCER, CATHETER9 reports
- Performer G09843INTRODUCER, CATHETER9 reports
- Performer G08956INTRODUCER, CATHETER8 reports
- Performer G07816INTRODUCER, CATHETER6 reports
- Performer G10626INTRODUCER, CATHETER6 reports
- Performer G13495INTRODUCER, CATHETER6 reports
- Performer G27023INTRODUCER, CATHETER6 reports
- Performer G07338INTRODUCER, CATHETER5 reports
- Performer G07487INTRODUCER, CATHETER5 reports
- Performer G09582INTRODUCER, CATHETER5 reports
- Performer G12424INTRODUCER, CATHETER5 reports
- Performer G13496INTRODUCER, CATHETER5 reports
- Performer G07337INTRODUCER, CATHETER4 reports
- Performer G09102INTRODUCER, CATHETER4 reports
- Performer G12664INTRODUCER, CATHETER4 reports
- Performer G27022INTRODUCER, CATHETER4 reports
- Performer G07605INTRODUCER, CATHETER3 reports
- Performer G09190INTRODUCER, CATHETER3 reports
- Performer G11316INTRODUCER, CATHETER3 reports
- Performer G27025INTRODUCER, CATHETER3 reports
- Performer G28445INTRODUCER, CATHETER3 reports
- Performer G07376INTRODUCER, CATHETER2 reports
- Performer G07913INTRODUCER, CATHETER2 reports
- Performer G07919INTRODUCER, CATHETER2 reports
- Performer G08139INTRODUCER, CATHETER2 reports
- Performer G08308INTRODUCER, CATHETER2 reports
- Performer G08550INTRODUCER, CATHETER2 reports
- Performer G08709INTRODUCER, CATHETER2 reports
- Performer G09109INTRODUCER, CATHETER2 reports
- Performer G10266INTRODUCER, CATHETER2 reports
- Performer G10270INTRODUCER, CATHETER2 reports
- Performer G10407INTRODUCER, CATHETER2 reports
- Performer G12782INTRODUCER, CATHETER2 reports
- Performer G07427INTRODUCER, CATHETER1 report
- Performer G07601INTRODUCER, CATHETER1 report
- Performer G07733INTRODUCER, CATHETER1 report
- Performer G08658INTRODUCER, CATHETER1 report
- Performer G08694INTRODUCER, CATHETER1 report
- Performer G08759INTRODUCER, CATHETER1 report
- Performer G08835INTRODUCER, CATHETER1 report
- Performer G09136INTRODUCER, CATHETER1 report
- Performer G09172INTRODUCER, CATHETER1 report
- Performer G09380INTRODUCER, CATHETER1 report
- Performer G10387INTRODUCER, CATHETER1 report
- Performer G10538INTRODUCER, CATHETER1 report
- Performer G11571INTRODUCER, CATHETER1 report
- Performer G11936INTRODUCER, CATHETER1 report
- Performer G13419INTRODUCER, CATHETER1 report
- Performer G21107INTRODUCER, CATHETER1 report
- Performer G27020INTRODUCER, CATHETER1 report
- Performer G28416INTRODUCER, CATHETER1 report
- Performer G28433INTRODUCER, CATHETER1 report
- Performer G28477INTRODUCER, CATHETER1 report
- Performer G29582INTRODUCER, CATHETER1 report
Recent Performer adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Material Split, Cut or Torn
IT WAS ORIGINALLY REPORTED THAT THE TIP OF THE DILATOR OF A PERFORMER INTRODUCER WAS "DISTORTED" WHEN IT CAME OUT OF THE PACKAGE. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT AND PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING AN UNSPECIFIED DILATOR FROM A DIFFERENT MANUFACTURER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 09FEB2026, A CRACK WAS NOTED ON THE TIP OF THE DILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431059 ↗MalfunctionFeb 10, 2026Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS RECEIVED 27MAR2026. THE COMPLAINT DEVICE WAS NOT LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306580 ↗MalfunctionFeb 10, 2026Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS RECEIVED 09FEB2026. THE SAME PROVIDER USED THE DEVICES ASSOCIATED WITH PATIENT IDENTIFIERS (B)(6). ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN. THERE WERE NO DIFFICULTIES ADVANCING THE INTRODUCER; HOWEVER, LEAKING WAS NOTED AROUND THE SHEATH. THE USER ATTEMPTED TO ADVANCE ANOTHER MANUFACTURER¿S TRANSSEPTAL NEEDLE THROUGH THE SHEATH. THE ISSUE WAS NOTED AT THE BEGINNING OF THE CASE. IT IS UNKNOWN WHAT CAUSED THE DEVICE TO SPLIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306572 ↗MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 23JAN2026. THE INTENDED PROCEDURE INVOLVED AN ARCH BRANCH. THE DEVICE LEAKED DURING USE. ANOTHER MANUFACTURER¿S HYDROPHILIC WIRE AND CATHETER WERE USED DURING THE PROCEDURE. RESISTANCE ENCOUNTERED DURING INSERTION AND REMOVAL OF THE DEVICE WAS NOT ¿MORE THAN USUAL.¿ THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY; HOWEVER, PER THE REPORTER, THIS WAS UNRELATED TO THE COMPLAINT DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23557037 ↗MalfunctionSep 22, 2025Detachment 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 23116064 ↗MalfunctionAug 18, 2025Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED 28AUG2025. THE PATIENT WAS HOSPITALIZED; HOWEVER, THERE HAS BEEN NO ALLEGATION THAT THE LEAK IN THE PERFORMER CAUSED OR CONTRIBUTED TO HOSPITALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829632 ↗MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 21AUG2025. THE ACCESS SITE WAS COMMON FEMORAL ARTERY. THE WIRE GUIDE INCLUDED WITH THE COMPLAINT DEVICE WAS USED DURING THE PROCEDURE. NO DEVICE WAS USED THROUGH THE SHEATH BEFORE THE LEAKING WAS NOTED, ONLY CONTRAST. THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797954 ↗MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A "STANDARD ILIAC PROCEDURE", A PERFORMER INTRODUCER LEAKED, CAUSING THE PATIENT TO LOSE "SLIGHTLY MORE BLOOD THAN NORMAL". THE PROCEDURE WAS COMPLETED NORMALLY, WITHOUT DISADVANTAGE FOR THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ANOTHER PERFORMER INTRODUCER ALSO LEAKED DURING THE PROCEDURE. THIS DEVICE WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534524 ↗MalfunctionJul 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS ORIGINALLY REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, THE SHEATH OF A 'PERFORMER INTRODUCER' WOULD NOT FLUSH. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER UNSPECIFIED SHEATH. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 01JUL2025, THE SILICONE DISC WAS DISLODGED IN THE HUB AND PUSHED DOWN IN THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395074 ↗MalfunctionJun 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNSPECIFIED CARDIAC PROCEDURE, THE TIP OF A PERFORMER INTRODUCER¿S DILATOR CRACKED. PER THE REPORTER, THE TIP WAS DEFORMED PRIOR TO USE. AS THE PHYSICIAN ATTEMPTED TO USE ¿OTHER INSTRUMENTS¿ TO CORRECT THE DEFORMATION, THE TIP CRACKED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PHOTOS PROVIDED BY THE CUSTOMER SHOW A SPLIT IN THE DILATOR TIP. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341377 ↗MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF AN "IMPELLER" DEVICE, THE HUB OF A PERFORMER INTRODUCER LEAKED FROM THE HEMOSTATIC VALVE UPON INSERTION INTO THE RIGHT COMMON FEMORAL ARTERY. THE PACKAGE WAS NOT DAMAGED PRIOR TO USE, AND THE DEVICE HAD BEEN STORED IN A ¿STACKED STATE¿. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE INTRODUCER. ANOTHER MANUFACTURER¿S WIRE GUIDE WAS IN THE LUMEN OF THE INTRODUCER WHEN THE BLOOD LEAK OCCURRED. THE INTRODUCER WAS REMOVED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE WITHOUT FURTHER PROBLEMS. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195247 ↗MalfunctionMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, THE VALVES OF TWO PERFORMER INTRODUCERS DISLODGED DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. THE NURSE OPENED THE FIRST INTRODUCER, WHICH DID NOT MAKE PATIENT CONTACT, AND FLUSHED THE SHEATH AND DILATOR WITH HEPARINIZED SALINE. UPON ATTEMPTED INSERTION OF THE DILATOR THROUGH THE SHEATH HUB/VALVE, THE VALVE "INFOLDED" AND THE DILATOR WOULD NOT PASS THROUGH THE SHEATH. A SECOND INTRODUCER WAS THEN OPENED AND PREPPED. REPORTEDLY, THE NURSE NOTICED MORE RESISTANCE THAN NORMAL WHEN ADVANCING THE DILATOR THROUGH THE SHEATH; HOWEVER, THE DILATOR PASSED THROUGH THE SHEATH TO "LOCKED POSITION", AND THE SHEATH WAS INSERTED INTO THE PATIENT'S GROIN OVER AN UNSPECIFIED LUNDERQUIST WIRE. PER THE REPORTER, WHEN THE DILATOR WAS REMOVED FROM THE SHEATH, BLOOD LEAKED FROM THE HUB/VALVE; THEREFORE, THE USER QUICKLY REINSERTED THE DILATOR TO STOP BLOOD LOSS, WHICH WAS ESTIMATED AT ONE-HUNDRED MILLILITERS. BECAUSE THE FACILITY DID NOT HAVE ADDITIONAL 14-FRENCH SHEATHS, AN UNSPECIFIED 16-FRENCH SHEATH, WHICH "WORKED FINE", WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107149 ↗InjuryApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A LOWER EXTREMITY ARTERIOGRAM WITH BALLOON DILATION VIA THE FEMORAL ARTERY, THE HUB OF A PERFORMER INTRODUCER SEPARATED FROM THE DEVICE. THE PATIENT HAD A HISTORY OF ARTERIOSCLEROSIS AND OCCLUSIVE DISEASE OF THE LOWER EXTREMITIES (FONTAINE STAGE IV). AFTER THE HUB SEPARATED, THE SHAFT OF THE DEVICE ¿FELL¿ INTO THE PATIENT¿S FEMORAL ARTERY AND WAS UNABLE TO BE REMOVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL REMOVAL OF THE SHAFT. THE SHAFT WAS SUCCESSFULLY REMOVED DURING THE ¿SECOND¿ SURGICAL PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS HUB SEPARATION. THE SHAFT MATERIAL ALSO APPEARS TO HAVE BEEN CUT OR PARTIALLY TORN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 21889758 ↗InjuryJan 23, 2025Break; Break
AS REPORTED, DURING AN UNKNOWN INTERVENTION, A PERFORMER INTRODUCER "TORE IN TWO" UPON REMOVAL OF THE DEVICE. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED VIA AN OPEN SURGICAL APPROACH "TO THE SCARPA". A SCALPEL WAS USED DURING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223034 ↗MalfunctionDec 11, 2024Unraveled Material; Unraveled Material
IT WAS ORIGINALLY REPORTED THAT PRIOR TO USE FOR AN UNKNOWN PROCEDURE THE USER FOUND THE WIRE GUIDE OF A PERFORMER INTRODUCER WAS BENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER UNSPECIFIED NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 02DEC2024, IT WAS NOTED THAT WIRE GUIDE HAD UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906470 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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