Performer G28438Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002284388), received between Sep 22, 2016 and Jul 27, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED 03AUG2023. A "LOT" OF FORCE WAS USED DURING ATTEMPTED REMOVAL OF THE FILTER, WHICH WAS STUCK IN THE PERFORMER INTRODUCER. THE FILTER WAS SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405049 ↗
• MalfunctionMar 1, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  AS REPORTED, PRIOR TO USE FOR A FILTER RETRIEVAL PROCEDURE, A PERFORMER INTRODUCER FRACTURED. THE DEVICE WAS OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE. THE USER ENCOUNTERED DIFFICULTY ADVANCING THE DILATOR INTO THE SHEATH; HOWEVER, PUSHED THE DILATOR THROUGH THE SHEATH HUB. THE FORCE REPORTEDLY CAUSED THE SHEATH TO BULGE AND FRACTURE, JUST BELOW THE HUB. THE EVENT OCCURRED ON THE BACK TABLE DURING PREPARATION OF THE DEVICE, WHICH NEVER MADE PATIENT CONTACT. THE FILTER WAS SUCCESSFULLY CAPTURED USING A LOOP SNARE TECHNIQUE WITH A WIRE, CATHETER, AND A 16-FRENCH PERFORMER INTRODUCER. 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 16461126 ↗
• MalfunctionNov 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER, THE PERFORMER INTRODUCER WAS USED. AS THEY WERE TAKING THE DILATOR OUT BEFORE PUTTING THE SNARE IN, IT WAS NOTED THAT THE ONE WAY VALVE HAD FAILED AND BLOOD WAS LEAKING FROM IT. THE COOK REPRESENTATIVE CONFIRMED IT WAS A MINIMAL AMOUNT OF BLOOD AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN REMOVED THE DEVICE IN ITS ENTIRETY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102553 ↗
• MalfunctionJul 26, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  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 7724044 ↗
• MalfunctionMar 1, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL, THE HAEMOSTATIC VALVE OF THE PERFORMER INTRODUCER FELL OFF. ANOTHER PERFORMER INTRODUCER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7305799 ↗
• MalfunctionDec 11, 2017Difficult to Insert; Material Separation; Difficult to Insert; Material Separation

  IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR, THE DILATOR WAS DIFFICULT TO INSERT INTO THE PERFORMER INTRODUCER SHEATH. THE DILATOR WAS REMOVED, RE-FLUSHED, AND WIPED DOWN. THE DILATOR WAS THEN ABLE TO BE SUCCESSFULLY RE-INSERTED INTO THE SHEATH; HOWEVER THERE WAS RESISTANCE UPON REMOVAL, AND SIGNIFICANT BLOOD FLOW WAS ENCOUNTERED AS THE SHEATH CHECK-FLO VALVE CAME OUT WITH THE DILATOR. THE PHYSICIAN PLACED A FINGER OVER THE SHEATH TO RESTRICT THE PATIENT'S BLOOD FLOW AND EXCHANGED THE SHEATH WITH ANOTHER ONE. IT WAS NOTED THAT THE BLOOD LOSS WITH NOT SIGNIFICANT. THE SHEATH WAS PLACED IN THE PATIENT'S FEMORAL ARTERY DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104536 ↗
• MalfunctionAug 8, 2017Crack

  WHEN PREPARING FOR A INFERIOR VENA CAVA FILTER RETRIEVAL PROCEDURE, THE PACKAGE FOR THE SHEATH WAS OPENED AND IT WAS NOTICED THAT THERE WAS A CRACK IN THE VERY TIP OF THE DILATOR. A SECOND SHEATH OF THE SAME LOT WAS OPENED AND THE SAME ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THE SECOND DILATOR WITH OUT ISSUE. THE FILTER WAS SUCCESSFULLY REMOVED WITH OUT ANY FURTHER ISSUE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774543 ↗
• MalfunctionMar 21, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN AORTIC GRAFT PROCEDURE, THE VALVE MEMBRANE WAS CHIPPED. THE VALVE MEMBRANE WAS CHIPPED OUT OF THE PERFORMER INTRODUCER. THE PATIENT WAS UNHARMED. WHEN THE DEVICE WAS RETURNED FOR INVESTIGATION THE ADDITIONAL FAILURE MODE OF HUB SEPARATION WAS NOTED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6421545 ↗
• InjuryJan 17, 2017Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT THE SEALING AT THE PROXIMAL END OF THE CATHETER WAS MISSING. THIS OCCURRENCE LED TO A HIGH-FLOW LEAKAGE OF BLOOD. THE INTRODUCER WAS THEN CHANGED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017, THE PHARMACIST REPORTED THE PATIENT EXPERIENCED A BLOOD LOST EQUIVALENT TO THAT OF A SYRINGE OF 10 ¿ 20 CC MAXIMUM. THE PATIENT WAS UNHARMED AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Blood Loss

  MAUDE report 6256418 ↗
• MalfunctionSep 22, 2016Bent; Material Separation; Bent; Material Separation

  IT WAS REPORTED THAT A SHEATH STARTED TO SEPARATE AND BEND DURING AN UNKNOWN PROCEDURE. THUS, MAKING THE DEVICE DIFFICULT AND UNSAFE FOR CONTINUED USE. THE PATIENT'S CONDITION IS UNKNOWN AS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5971601 ↗