Cook G06299Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002062993), received between May 1, 2018 and Apr 2, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fluid/Blood Leak

  UPON RETURN OF AN UNUSED DEVICE ASSOCIATED WITH ANOTHER COMPLAINT (REPORTED UNDER PATIENT IDENTIFIER (B)(6)), THE UNUSED TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED FROM THE TWIST-LOCK FITTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767661 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED. THE DEVICE DID NOT SEPARATE, AND IT WAS CONNECTED TO AN UNSPECIFIED CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209105 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, TWO TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTERS LEAKED AT THE VALVES. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

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

  MAUDE report 23760933 ↗
• MalfunctionJan 17, 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 16183298 ↗
• MalfunctionJul 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED BLOOD DURING AN UNSPECIFIED PROCEDURE. THE LEAK PERSISTED DESPITE THE INSERTION OF A 0.014" WIRE THROUGH THE DEVICE. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 15040965 ↗
• MalfunctionJun 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A NEURO ANGIOGRAM, A TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED. THE ADAPTER WAS PLACED ON THE END OF AN UNSPECIFIED 6 FRENCH GUIDE CATHETER/SHEATH, AND AN UNKNOWN 0.014-INCH WIRE WAS PLACED THROUGH THE DEVICE. BLOOD REPORTEDLY LEAKED FROM THE WIRE PORT, DESPITE THE TUOHY BEING TIGHTENED AS MUCH AS POSSIBLE. 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 14633572 ↗
• MalfunctionMar 31, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING A CEREBRAL EMBOLIZATION AND USING A TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER, IT WAS NOTED TO BE LEAKING BLOOD OUT OF THE BACK. THREE OF THESE DEVICES WERE BEING USED AT THE SAME TIME AND ALL HAD THE SAME PROBLEM. THE ACCESS SITE WAS THE RIGHT GROIN, AND THE TARGET SITE FOR THE PROCEDURE WAS THE CEREBRAL VASCULATURE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH OTHER SIDE ARM ADAPTERS FROM ANOTHER MANUFACTURER. THE REP TESTED AN UNUSED DEVICE FROM THIS LOT NUMBER AND ALSO WITNESSED LEAKING. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964473 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A MECHANICAL THROMBECTOMY PROCEDURE, TWO TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTERS LEAKED NORMAL SALINE AND CONTRAST BEHIND THE Y-CONNECTOR. THE DEVICE WAS CONNECTED TO A GUIDING CATHETER, AND AN UNKNOWN WIRE GUIDE AND PRESSURE LINE WERE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CORONARY Y-CONNECTOR. 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 13508118 ↗
• MalfunctionFeb 8, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11292944 ↗
• MalfunctionDec 14, 2020Fracture; Fracture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003383 ↗
• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683488 ↗
• MalfunctionMay 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED 22JUL2020. AN UNKNOWN 0.014 INCH GUIDEWIRE WAS USED DURING THE PROCEDURE. THE DEVICES HAD BEEN STORED IN A STORAGE BIN IN THE CATH LAB.

  Patient problems: No Patient Involvement

  MAUDE report 10078886 ↗
• MalfunctionMay 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED 22JUL2020. AN UNKNOWN 0.014 INCH GUIDEWIRE WAS USED DURING THE PROCEDURE. THE DEVICES HAD BEEN STORED IN A STORAGE BIN IN THE CATH LAB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10078863 ↗
• MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, DURING AN EMBOLIZATION PROCEDURE, THE TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED WHEN CONNECTED TO ANOTHER MANUFACTURER'S CATHETER. REPORTEDLY, THE COMPLAINT DEVICE WOULD NOT TIGHTEN DOWN ON THE MICROCATHETER. THE BACK-END LEAKED. THIS OCCURRED DURING PREPPING AND DURING THE PROCEDURE. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PROCEDURE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THIS EVENT OCCURRED IN THREE DISTINCT PROCEDURES WHICH ARE REPORTED UNDER MEDWATCH REPORT REFERENCES: 1820334-2019-00746 AND 1820334-2019-00748. EACH OF THESE THREE EVENTS OCCURRED ON EITHER (B)(6) 2019. THE COMPLAINT DEVICE FOR THIS EVENT WAS DISCARDED AT THE FACILITY. REPORTEDLY, FOUR UNUSED DEVICES ARE AVAILABLE TO AID IN THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478927 ↗
• MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, DURING AN EMBOLIZATION PROCEDURE, THE TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED WHEN CONNECTED TO ANOTHER MANUFACTURER'S CATHETER. REPORTEDLY, THE COMPLAINT DEVICE WOULD NOT TIGHTEN DOWN ON THE MICROCATHETER. THE BACK-END LEAKED. THIS OCCURRED DURING PREPPING AND DURING THE PROCEDURE. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PROCEDURE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THIS EVENT OCCURRED IN THREE DISTINCT PROCEDURES WHICH ARE REPORTED UNDER MEDWATCH REPORT REFERENCES: 1820334-2019-00747; 1820334-2019-00746. EACH OF THESE THREE EVENTS OCCURRED ON EITHER (B)(6) 2019. THE COMPLAINT DEVICE FOR THIS EVENT WAS DISCARDED AT THE FACILITY. REPORTEDLY, FOUR UNUSED DEVICES ARE AVAILABLE TO AID IN THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478905 ↗
• MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, DURING AN EMBOLIZATION PROCEDURE, THE TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED WHEN CONNECTED TO ANOTHER MANUFACTURER'S CATHETER. REPORTEDLY, THE COMPLAINT DEVICE WOULD NOT TIGHTEN DOWN ON THE MICROCATHETER. THE BACK-END LEAKED. THIS OCCURRED DURING PREPPING AND DURING THE PROCEDURE. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PROCEDURE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THIS EVENT OCCURRED IN THREE DISTINCT PROCEDURES WHICH ARE REPORTED UNDER MEDWATCH REPORT REFERENCES: 1820334-2019-00747 AND 1820334-2019-00748. EACH OF THESE THREE EVENTS OCCURRED ON EITHER (B)(6) 2019. THE COMPLAINT DEVICE FOR THIS EVENT WAS DISCARDED AT THE FACILITY. REPORTEDLY, FOUR UNUSED DEVICES ARE AVAILABLE TO AID IN THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478902 ↗
• MalfunctionMay 1, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE VALVE ON THE TUOHY-BORST SIDE-ARM ADAPTER DID NOT SEAL. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7477288 ↗
• MalfunctionMay 1, 2018Leak/Splash

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE, THE TUOHY-BORST SIDE-ARM ADAPTER WAS LEAKING. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476995 ↗