Cook G26941Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002269415), received between Jul 11, 2018 and Sep 4, 2019 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959775 ↗
• InjuryDec 3, 2018Crack; Crack

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8124772 ↗
• InjuryNov 19, 2018Crack; Crack

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8085868 ↗
• InjuryNov 12, 2018Crack; Crack

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER PLACED ON (B)(6) 2018 IN THE RIGHT FEMORAL VEIN WAS FOUND CRACKED ON (B)(6) 2018. THE LINE WAS REMOVED AND A REPLACEMENT DEVICE WAS INSERTED AS THE DEVICE WAS BEING USED FOR INTERMITTENT MEDICATION ADMINISTRATION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8061558 ↗
• InjuryOct 11, 2018Crack; Crack

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS FOUND CRACKED AT THE HUB ON (B)(6) 2018. THE DEVICE WAS INITIALLY PLACED ON (B)(6) 2018 AND CONNECTED TO A SMARTSITE NEEDLE FREE VALVE. THE DEVICE WAS REMOVED AND A LIKE DEVICE WAS PLACED IN A DIFFERENT SITE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7957330 ↗
• InjuryAug 21, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS PLACED INTRA-OPERATIVELY DURING A RIGHT INTERNAL JUGULAR ARTERIAL SWITCH PROCEDURE ON (B)(6) 2018. ON (B)(6) 2018, A CRACK WAS IDENTIFIED ON THE CATHETER. THE PATIENT WAS RECEIVING IV MEDICATIONS AND CONTINUOUS FLUIDS. AS REPORTED, THE PATIENT REQUIRED ANOTHER CENTRAL LINE TO BE PLACED WITH A NEW PUNCTURE SITE, HOWEVER, DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7800660 ↗
• InjuryJul 11, 2018Fracture; Fracture

  IT WAS REPORTED A CENTRAL LINE WAS PLACED ON (B)(6) 2018 AT 0545AM UTILIZING A 5FR TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER (CVC). ON (B)(6) 2018, THE FLUID WAS FOUND TO BE LEAKING FROM THE CRACKED BLUE HUB. AS A RESULT THE CATHETER HAD TO BE REMOVED AND ANOTHER CENTRAL LINE WAS PLACED. IT WAS FURTHER STATED THERE IS "THE POSSIBILITY THAT INDIVIDUALS ARE SCREWING THE END CAPS ON TOO TIGHT". NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 7680514 ↗