Performer G08957Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00827002089570), received between Aug 29, 2014 and Nov 14, 2025 — classified as 3 deaths, 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  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 19527036 ↗
• InjuryDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18266160 ↗
• MalfunctionOct 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS INITIALLY REPORTED, PRIOR TO PATIENT CONTACT, THE DILATOR WAS UNABLE TO BE INSERTED INTO A PERFORMER INTRODUCER DURING PREPARATION OF THE DEVICE FOR AN UNKNOWN PROCEDURE. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON (B)(6) 2023, THE SILICONE DISC WAS DISLODGED WITHIN THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852479 ↗
• MalfunctionOct 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS INITIALLY REPORTED, PRIOR TO PATIENT CONTACT, THE DILATOR WAS UNABLE TO BE INSERTED INTO A PERFORMER INTRODUCER DURING PREPARATION OF THE DEVICE FOR AN UNKNOWN PROCEDURE. THE DEVICE WAS NOT USED, AND ANOTHER INTRODUCER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 22SEP2023, THE SILICONE DISC WAS DISLODGED WITHIN THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852166 ↗
• MalfunctionSep 8, 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 17715186 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  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 17681901 ↗
• MalfunctionFeb 14, 2023Sharp Edges; Sharp Edges

  AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING DELIVERY OF A VALVE VIA ACCESS IN THE RIGHT FEMORAL ARTERY, A SHARP "BARB" WAS FOUND AT THE TIP A PERFORMER INTRODUCER. UPON OPENING THE PACKAGE, THE DEVICE APPEARED NORMAL AND WAS THEREFORE USED. UPON REMOVAL OF THE SHEATH FROM THE PATIENT FOR A SHEATH EXCHANGE, RESISTANCE WAS ENCOUNTERED. AFTER REMOVAL, THE USER NOTICED A SHARP "BARB" AT THE TIP OF THE DEVICE. ANOTHER SHEATH 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 DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373310 ↗
• InjuryJan 30, 2023Sharp Edges; Sharp Edges

  AS REPORTED, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, THE TIP OF A PERFORMER INTRODUCER WAS NOTED TO BE SHARP. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND RESISTANCE WAS REPORTED UPON ADVANCEMENT OF THE COMPLAINT DEVICE. UPON REMOVAL OF THE SHEATH, A SHARP, IRREGULAR EDGE WAS NOTED AT THE SHEATH TIP. RESISTANCE WAS NOT REPORTED UPON REMOVAL OF THE DEVICE. THE ACCESS SITE WAS NOT SCARRED. RESISTANCE WAS NOT ENCOUNTERED UPON ADVANCEMENT OR REMOVAL OF AN UNSPECIFIED 6-FRENCH DIAGNOSTIC CATHETER THROUGH THE COMPLAINT DEVICE. A SECOND SHEATH WAS OPENED, PREPPED, AND PLACED IN THE PATIENT. UPON COMPLETION OF THE CASE, THE SECOND SHEATH WAS REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE NOTED TO THE SECOND SHEATH, AND NO REPORTED MALFUNCTION OF THAT DEVICE. SIGNIFICANT BLEEDING WAS REPORTED AT THE ACCESS SITE AT THE END OF THE CASE. PER THE REPORTER, IT APPEARED THAT THE VESSEL WAS TORN DURING DEVICE INSERTION, LEADING TO AN INABILITY TO ACHIEVE HEMOSTASIS; THEREFORE, A SURGICAL CUT-DOWN WAS PERFORMED TO REPAIR THE FEMORAL ARTERY. THE PATIENT WAS HOSPITALIZED TO RECOVER FROM THE ARTERIAL REPAIR. NO PART OF THE COMPLAINT DEVICE REMAINED IN THE PATIENT. BLOOD PRODUC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16264691 ↗
• MalfunctionJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE VALVE DISLODGED FROM A PERFORMER INTRODUCER. DURING DEVICE PREPARATION, THE USER ATTEMPTED TO INSERT THE DILATOR INTO THE SHEATH; HOWEVER, THE VALVE SLIPPED BACKWARDS. A NEW INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183968 ↗
• MalfunctionOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TAVI (TRANSCATHETER AORTIC VALVE IMPLANTATION) PROCEDURE, BLOOD LEAKED THROUGH A PERFORMER INTRODUCER'S HUB/VALVE, WHICH WAS PLACED IN THE FEMORAL ARTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543859 ↗
• MalfunctionSep 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, BLACK PARTICLES WERE FLUSHED FROM A PERFORMER INTRODUCER DURING PREPARATION OF THE DEVICE. AS THE DEVICE WAS FLUSHED WITH SALINE, SEVERAL BLACK PARTICLES WERE FLUSHED FROM THE SHEATH INTO THE SALINE BOWL, AND BLACK PARTICLES WERE ALSO NOTED IN THE HUB/CHECK-FLO VALVE. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383413 ↗
• MalfunctionAug 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER'S SILICONE VALVE DISLODGED AND LEAKED BLOOD. PER THE REPORTER, THIS INCREASED THE RISK OF BLEEDING/HEMORRHAGE; HOWEVER, THERE HAS BEEN NO REPORT OF HEMORRHAGE AND NO REPORT THAT ANY INTERVENTION WAS REQUIRED TO TREAT BLOOD LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148381 ↗
• MalfunctionSep 29, 2021Leak/Splash; Leak/Splash

  AS REPORTED, DURING AN IVC FILTER REMOVAL A PERFORMER INTRODUCER LEAKED FROM THE VALVE. ACCESS WAS GAINED FROM THE RIGHT INTERNAL JUGULAR VEIN. AS THE USER ADVANCED THE SHEATH THEY FOUND THE VALVE LEAKED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548183 ↗
• MalfunctionAug 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341217 ↗
• MalfunctionJul 12, 2021Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED 07JUL2021: THE DEVICE DID MAKE PATIENT CONTACT. THE EVENT OCCURRED DURING DEVICE INSERTION, AND THE ACCESS SITE WAS THE FEMORAL ARTERY. THE SHEATH WAS ONLY IN PLACE FOR LESS THAN 1 MINUTE. NO TORTUOUS, SCARRED, OR CALCIFIED ANATOMY WAS NOTED. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY EXTRA TREATMENT FOR THE NOTED UNSPECIFIED AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12152076 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED 08JUN2021. THE DILATOR WAS NOT IN THE SHEATH WHEN THE LEAK OCCURRED. THE DEVICE DID NOT SEPARATE. NO RESISTANCE WAS FELT DURING INSERTION OR REMOVAL OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665035 ↗
• MalfunctionMar 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021: THE LEAKING WAS FOUND AFTER THE DEVICE HAD BEEN INSERTED INTO THE PATIENT AND THE DILATOR HAD BEEN REMOVED. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEED FOR ANY BLOOD PRODUCTS OR ADDITIONAL TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 11516093 ↗
• MalfunctionApr 15, 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 Consequences Or Impact To Patient

  MAUDE report 8515778 ↗
• MalfunctionApr 2, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, THERE WAS A PUNCTURE IN THE PERFORMER INTRODUCER. A (B)(6) MALE WEIGHING (B)(6) WAS UNDERGOING A "WATCHMEN" LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS NEITHER SCARRED, CALCIFIED, OR ANGLED. AT THE TIME OF THE EVENT, THE COMPLAINT DEVICE HAD BEEN IN PLACE APPROXIMATELY TWO HOURS. OTHER DEVICES USED AT THE TIME OF THE EVENT WERE 14FR WATCHMEN DEVICE, 14FR WATCHMEN SHEATH, 8.5FR UNSPECIFIED TRANSSEPTAL NEEDLE AND SHEATH. REPORTEDLY, EXTRA PER CLOSE DEVICES WERE REQUIRED. NO BLOOD LOSS HAS BEEN REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EFFECTS. NO ADDITIONAL EVENT DETAILS WERE PROVIDED REGARDING THE REPORTED "PUNCTURE" IN THE PERFORMER INTRODUCER. NO ADDITIONAL PROCEDURES WERE REQUIRED. A PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S ANATOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475430 ↗
• MalfunctionMay 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE DILATOR OF THE PERFORMER INTRODUCER CAME OUT AS IT WAS INTRODUCED INTO THE PATIENT'S ANATOMY. THIS CAUSED A LEAKAGE OF BLOOD. A PORTION OF THE DEVICE REMAINED IN PLACE TO KEEP ACCESS, AND A NEW INTRODUCER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE BLOOD LOSS WAS NOT QUANTIFIED; HOWEVER THE PATIENT DID NOT REQUIRE OTHER PROCEDURES AS A RESULT OF THIS OCCURRENCE. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503351 ↗