Cook G43558Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002435582), received between Jul 27, 2017 and Mar 28, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2018Entrapment of Device; Retraction Problem; Split

  THE COMPLAINANT REPORTED THAT AN ABDOMINAL PANCREATITIS WAS PERFORMED AND THERE WAS INABILITY TO WITHDRAW THE GUIDE WIRE AFTER INSERTING THE PIGTAIL CATHETER. THE DOCTOR MANAGED TO WITHDRAW THE GUIDE WIRE AND FOUND THAT THE TIP OF THE GUIDE WIRE SPLIT INTO TWO. THE DOCTOR REINSERTED THE PIGTAIL CATHETER USING A NEW GUIDE WIRE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETELY. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377930 ↗
• MalfunctionMar 28, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTION OF THE PERICARDIOCENTESIS CATHETER, IT WAS DISCOVERED THAT FLUID WAS LEAKING FROM THE HUB AREA. THE CATHETER WAS NOT REMOVED, AS THE PHYSICIAN DID NOT WANT TO RE-INSERT ANOTHER CATHETER INTO THE PATIENT. THE CATHETER CONTINUED TO LEAK UNTIL IT WAS TAKEN OUT AT DISCHARGE ON (B)(6). THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377653 ↗
• MalfunctionMar 28, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER FROM THE PERICARDIOCENTESIS CATHETER SET, IT WAS DISCOVERED THAT FLUID WAS LEAKING FROM THE HUB AREA. A NEW CATHETER WAS INSERTED TO COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377329 ↗
• MalfunctionMar 27, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER FROM THE PERICARDIOCENTESIS CATHETER SET, IT WAS DISCOVERED THAT FLUID WAS LEAKING FROM THE HUB AREA. THE LEAKING CATHETER WAS THEN REMOVED AND A NEW ONE INSERTED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375186 ↗
• InjuryJul 27, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A DRAINAGE PROCEDURE. THE CUSTOMER REPORTS THAT ALL STEPS STATED ON THE DEVICE PACKAGE WERE FOLLOWED DURING THE DRAIN INSERTION. THE MEDICAL OFFICER SUCCESSFULLY ASPIRATED HEMOSEROUS ASCITIC FLUID ON THE SECOND ATTEMPT WITH ULTRASOUND GUIDANCE. THE PHYSICIAN INSERTED THE GUIDE WIRE WITHOUT RESISTANCE. THE DRAIN TIP BROKE SHORTLY AFTER BEING INSERTED INTO THE ABDOMEN VIA THE SELDINGER TECHNIQUE. THE DOCTORS IMMEDIATELY ABORTED THE PROCEDURE AND REMOVED THE DRAIN. THE DRAIN TIP WAS FOUND TO BE "FRIABLE AND BROKE WITH MINIMAL STRESS" UPON CLOSE EXAMINATION. THE DOCTORS THEN REALISED THAT THE DRAIN SET WAS AN EXPIRED PRODUCT. THE DOCTORS REMOVED THE GUIDE WIRE PROMPTLY. AN ABDOMINAL X-RAY CONFIRMED THAT THE DRAIN TIP WAS LEFT IN-SITU OF THE PATIENT'S ABDOMEN. THE PATIENT DEVELOPED A FEVER AND ABDOMINAL WALL CELLULITIS THREE DAYS ((B)(6) 2017) FOLLOWING THE ABORTED PROCEDURE. THE PATIENT UNDERWENT WOUND EXPLORATION AND REMOVAL OF THE RETAINED FOREIGN BODY ON (B)(6) 2017 UNDER LOCAL ANESTHESIA WITH NO IMMEDIATE COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE EXPIRED DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6747531 ↗