Cook G50779Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002507791), received between Apr 18, 2017 and Oct 21, 2025 — classified as 1 death, 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Material Separation; Material Separation

  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 23348371 ↗
• MalfunctionJun 23, 2025Material Separation; Material Split, Cut or Torn; Material Separation; 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 22307946 ↗
• MalfunctionMar 25, 2025Difficult to Remove; Material Separation; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION PROVIDED 26MAR2025: A LIVER BIOPSY WAS BEING PERFORMED FOR A 69-YEAR-OLD MALE PATIENT. THE LIVER ACCESS AND BIOPSY SET WAS SAID TO BE USED ACCORDING TO THE IFU. THE PHYSICIAN WAS ABLE TO PROBE THE VENA HEPATICA WITH A CURVED CATHETER AND PLACED AN AMPLATZ WIRE (FROM COOK) IN THE VENA HEPATICA AND WAS ABLE TO DO THE PRESSURE MEASUREMENT. HE THEN PASSED THE INTRODUCER WITH THE STIFFENING CANNULA AND THE STRAIGHT BLACK CATHETER OVER THE WIRE. HE REACHED THE HEPATIC VEIN WITH THE TIP OF THE BLACK CATHETER. HOWEVER, HE WAS UNABLE TO ADVANCE THE INTRODUCER. AS THERE IS A TRANSITION BETWEEN THE INTRODUCER AND THE BLACK CATHETER, IT WAS NOT POSSIBLE FOR HIM TO ADVANCE THE INTRODUCER INTO THE HEPATIC VEIN. HE HAD PREVIOUSLY BENT THE STIFF CANNULA A LITTLE MORE (CATHETER AND WIRE WERE IN THE CANNULA TO PREVENT KINKING). HE THEN WITHDREW THE BLACK CATHETER (LEAVING THE WIRE IN PLACE). HE FELT RESISTANCE AND COULD NOT REMOVE IT. HE HAD NO CHOICE BUT TO PULL IT ALL OUT TOGETHER. HE REALIZED THAT THE CATHETER HAD SPLIT OPEN. HE TRIED THE INTERVENTION AGAIN WITH A NEW SET (SAME LOT NUMBER); THE SAME THING HAPPENED. AT THE END, THE PHYSICIAN WAS UNABLE TO PERFORM THE BIOPSY

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

  MAUDE report 21690472 ↗
• MalfunctionAug 13, 2024Material Separation; Material Separation

  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 19973241 ↗
• MalfunctionAug 13, 2024Detachment 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 19973050 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT REQUIRED A LIVER ACCESS AND BIOPSY SET FOR A TRANSJUGULAR LIVER BIOPSY PROCEDURE. DURING THE PROCEDURE, THE PROXIMAL HUB SEPARATED FROM THE BODY OF THE CATHETER DUE TO "MANIPULATION" OF THE DEVICE. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14148136 ↗
• MalfunctionDec 13, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; 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: Insufficient Information

  MAUDE report 12988837 ↗
• MalfunctionJun 25, 2021Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS PROVIDED ON 20SEP2021. THE ACCESS SITE WAS THE RIGHT INTERNAL JUGULAR VEIN. THE RIGHT HEPATIC VEIN WAS ACCESSED TO PUNCTURE THE LIVER. THERE WERE NO ANATOMIC DIFFICULTIES IN GAINING ACCESS TO THE ORGAN. A SECOND NEEDLE WAS OPENED AFTER THE FIRST ONE FAILED AND EXIBITED THE SAME FAILURE DURING THE SAME PROCEDURE. THE CATHETER SHAFT WAS SHAVED BY THE LARGE COLAPINTO NEEDLE. THE "SHEAR" WAS IDENTIFIED WHEN ATTEMPTING TO REMOVE THE BLACK INNER SHEATH, IT COULD NOT BE REMOVED SMOOTHLY. THE TRANSJUGULAR APPROACH WAS ABORTED AFTER THE FAILURE. NO FORCE WAS EXERTED ON THE SEPARATED HUB OF THE INTRODUCER. THE EQUIPMENT WAS REPORTED TO HAVE BEEN USED PER INSTRUCTIONS FOR USE (IFU), FOLLOWING THE STEPS PER IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068540 ↗
• InjuryApr 9, 2021Material Separation; Material Separation

  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 11644612 ↗
• MalfunctionJun 29, 2020Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; 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 Known Impact Or Consequence To Patient

  MAUDE report 10207194 ↗
• InjuryJun 26, 2020Material Separation; Material Separation

  AS REPORTED, A (B)(6) OLD PATIENT REQUIRED THE USE OF A LIVER ACCESS AND BIOPSY SET FOR A LIVER BIOPSY PROCEDURE. DURING THE PROCEDURE, A "FAULTY GESTURE" LED TO THE RUPTURE OF THE DISTAL END OF THE BIOPSY CATHETER. THE RUPTURE LED TO A PORTION OF THE CATHETER SEPARATING AND CREATING A FOREIGN BODY WITHIN THE PATIENT. AFTER AN ATTEMPT TO RECOVER IT, THE FOREIGN BODY MIGRATED INTO THE PULMONARY ARTERIES. THE DEVICE WAS THEN VISUALIZED USING CONVENTIONAL RADIOLOGY AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH USE OF INTERVENTIONAL RADIOLOGY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10200178 ↗
• MalfunctionAug 1, 2019Break; Break

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 01AUG2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851514 ↗
• InjuryApr 25, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED A ¿(CORDIS) MULTIPURPOSE CATHETER WAS PLACED OVER WIRE THROUGH THE METAL INTRODUCER PORTION (WITHIN ITS BLUE SHEATH) OF THE LIVER ACCESS AND BIOPSY SET WITHIN THE MIDDLE HEPATIC VEIN. ON RETRACTING THE CATHETER THROUGH THE LIVER ACCESS AND BIOPSY SET, THE CATHETER TIP CAME OFF AND MIGRATED TO THE LEFT PULMONARY ARTERY. IT WAS THOUGHT THAT THIS WAS A FAULTY CATHETER AND A NEW (CORDIS MULTIPURPOSE) CATHETER WAS PLACED TO POSITION THE BIOPSY KIT FOR A FURTHER SAMPLE. ON WITHDRAWING THIS SECOND CATHETER THE TIP OF THE CATHETER ALSO CAME OFF AND MIGRATED TO THE RIGHT PULMONARY ARTERY". IT WAS ALSO REPORTED THE DEVICE WAS REMOVED SAFELY AND "THE TWO MIGRATED FRAGMENTS OF THE CATHETERS WERE THEN RETRIEVED WITH SNARES." THE PATIENT CONDITION IS REPORTED TO BE "FINE". NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 8549554 ↗
• InjuryMar 25, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8448944 ↗
• MalfunctionFeb 25, 2019Difficult to Remove; Difficult to Remove

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367216 ↗
• MalfunctionOct 10, 2018Material Separation; Stretched; Material Split, Cut or Torn; Material Separation; Stretched; Material Split, Cut or Torn

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7953562 ↗
• InjuryJun 25, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A TRANSJUGULAR LIVER BIOPSY USING A LIVER ACCESS AND BIOPSY SET, THE CATHETER BECAME STUCK INSIDE THE CO-AX SYSTEM AND COULD NOT BE WITHDRAWN. AFTER SOME MANIPULATION OF THE DEVICE, THE PHYSICIAN FORCEFULLY PULLED IT OUT AND THE TIP SHEARED OFF. AN ADDITIONAL PROCEDURE USING A SNARE WAS PERFORMED FOR THE RETRIEVAL OF THE TIP THROUGH THE GROIN. THE RETRIEVAL WAS SUCCESSFUL AND A SECOND KIT WAS OPENED TO CONTINUE WITH THE TRANSJUGULAR BIOPSY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7635680 ↗
• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED DURING A LIVERY BIOPSY USING A LIVER ACCESS AND BIOPSY SET, THE TIP OF THE CATHETER SHEERED OFF INSIDE THE SHEATH. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF AN ALTERNATIVE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579005 ↗
• MalfunctionJun 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A LIVER ACCESS AND BIOPSY SET WAS USED DURING A TRANSJUGULAR LIVER BIOPSY AND THE SHEATH WOULD NOT ADVANCE. THE DEVICE BECAME LODGED AND WAS DIFFICULT TO REMOVE, HOWEVER, THE OPERATOR USED EXCESSIVE FORCE TO REMOVE IT SUCCESSFULLY. UPON EXAMINING THE DEVICE, THE BLACK INTRODUCER HAD BROKEN OFF AND WAS LODGED IN THE END OF THE SHEATH. ANOTHER LIKE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560042 ↗
• DeathDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PATIENT EXPIRED FOLLOWING THE USAGE OF THE LIVER ACCESS AND BIOPSY SET DURING A TRANSJUGULAR LIVER BIOPSY. ACCESS HAD BEEN GAINED FROM THE JUGULAR VEIN TO PERFORM THE PROCEDURE, AND THE PROCEDURE SEEMED TO BE COMPLETED SUCCESSFULLY; THE DEVICE WAS REPORTED TO HAVE WORKED WITHOUT ANY PROBLEMS. HOWEVER, THE PATIENT EXPERIENCED BLEEDING POST PROCEDURE, WHICH WAS BELIEVED TO HAVE STEMMED FROM AN ARTERY WHICH MAY HAVE BEEN DAMAGED DURING THE PROCEDURE; ARTERIAL EMBOLIZATION FOR HEMOSTASIS WAS PERFORMED TWICE FOLLOWING THE PROCEDURE. PATIENT INTRINSIC SEVERE ASCETIC FLUID AND SYSTEMIC BLEEDING WERE OBSERVED. THE PATIENT ULTIMATELY EXPIRED. NO FURTHER INFORMATION WAS AVAILABLE, AND THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN. WE HAVE REQUESTED ADDITIONAL INFORMATION INCLUDING MEDICAL RECORDS, CAUSE OF DEATH, FURTHER ELABORATION OF CLINICAL EVENTS SURROUNDING THE DEVICE AND BIOPSY PROCEDURE DETAILS. NO ADDITIONAL INFORMATION RELATED TO THE EVENT IS AVAILABLE AT THIS TIME.

  Patient problems: Ascites; Blood Loss; Death

  MAUDE report 7143628 ↗
• InjuryOct 19, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE CATHETER CONTAINED IN THE LIVER ACCESS AND BIOPSY SET SET BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE. A COMPONENT BROKE OFF INTO THE PATIENT, BUT IT WAS REPORTEDLY RETRIEVED WITH NO HARM TO THE PATIENT THEREAFTER. FURTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE CIRCUMSTANCE SURROUNDING THE USAGE AND HANDLING OF THE DEVICE LEADING UP TO THE BREAK WERE NOT REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 6962976 ↗
• MalfunctionOct 17, 2017Disconnection; Disconnection

  THE INTERNATIONAL CUSTOMER REPORTED THAT, THE HUB OF THE LIVER ACCESS AND BIOPSY SET GOT DISCONNECTED. THE TRANSJUGULAR LIVER SYSTEM HAD BEEN INTRODUCED PREASSEMBLED WITH A 5 FRENCH STRAIGHT CATHETER INTO THE SELECTED HEPATIC VEIN, AND UPON WITHDRAWAL OF THE CATHETER, THE HUB DISCONNECTION OCCURRED. THE OPERATOR MANAGED TO TAKE IT OUT OVER THE WIRE AND COMPLETE THE BIOPSY WITH NO FURTHER PROBLEMS AND NO ADVERSE EVENTS REPORTED. THE CUSTOMER CONFIRMED THAT THERE WERE NO ADDITIONAL PROCEDURES, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955092 ↗
• MalfunctionSep 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE, THE 5 FRENCH CATHETER COULD NOT BE REMOVED FROM THE SHEATH; RESISTANCE WAS ENCOUNTERED. THE CATHETER DISLODGED FRO THE PLASTIC HUB, AND THE CATHETER WAS "SHAVED OFF" AT THE DISTAL END. THE ACCOUNT FURTHER CLARIFIED THAT NO PATIENT ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE REPORTED ISSUE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. THE PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6879511 ↗
• MalfunctionApr 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A TRANSJUGULAR LIVER BIOPSY USING A LIVER ACCESS AND BIOPSY SET. THE HUB BROKE AND DISCONNECTED FROM THE BLACK CATHETER. THE FORCES APPLIED TO THE DEVICE AND CONDITIONS SURROUNDING THE EVENT ARE NOT KNOWN. A NEW CATHETER SET WAS OBTAINED AND REPLACEMENT CATHETER WAS USED. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO UNINTENDED SECTION OF THE DEVICE REMAINED WITHIN THE PATIENT. THE PRODUCT IS REPORTEDLY AVAILABLE FOR EVALUATION; NO DEVICE WAS RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501395 ↗