Cook G10643Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002106437), received between Jun 14, 2017 and Mar 28, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 6, 2020Terminated

   The printed expiration dates are incorrect.

   Z-1565-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2018Failure to Advance

  IT WAS REPORTED THAT THE DEVICE WAS USED FOR PERICARDIAL DRAINAGE AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE CATHETER OVER THE WIRE GUIDE. HOWEVER, THE PHYSICIAN REMOVED THE CATHETER AND WIRE TOGETHER AS A UNIT SINCE THERE WAS INABILITY TO ADVANCE THE CATHETER. THE WIRE GUIDE WAS REPLACED WITH ANOTHER MANUFACTURER'S WIRE GUIDE, THEN THE SAME CATHETER COULD ADVANCE OVER THE REPLACEMENT AND COULD BE PLACED FOR DRAINAGE SUCCESSFULLY. IT WAS FURTHER NOTED THAT THE COMPLAINT WIRE GUIDE WAS ELONGATED AND THE USER MAY HAVE TRIED TO REMOVE THE CATHETER WHILE THE WIRE GUIDE REMAINED IN THE PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378149 ↗
• MalfunctionDec 12, 2017Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE WIRE GUIDE IN THE PERICARDIOCENTESIS CATHETER SET WAS PLACED INTO THE PATIENT'S PERICARDIAL SAC AT THE APEX, AND THE CATHETER WAS ADVANCED OVER THE WIRE GUIDE. THEN, THE USER ATTEMPTED TO REMOVE THE WIRE GUIDE; HOWEVER, THE WIRE GUIDE GOT CAUGHT WITHIN THE CATHETER AND COULD NOT BE REMOVED. THEN, THE COIL OF THE WIRE GUIDE GOT ELONGATED. THE WIRE GUIDE AND CATHETER WERE REMOVED FROM THE PATIENT TOGETHER, AND ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PER THE PHYSICIAN, "REGARDING ADVANCEMENT/REMOVAL OF THE WIRE GUIDE, THERE WAS CLEAR DIFFERENCE BETWEEN THE COMPLAINT DEVICE AND REPLACEMENT DEVICE. I THINK THERE WAS PROBLEM WITH THE WIRE GUIDE OR THE CATHETER".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107548 ↗
• MalfunctionJun 14, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A PERICARDIOCENTESIS USING A PERICARDIOCENTESIS CATHETER SET. WHEN HE APPLIED NEGATIVE PRESSURE USING A SYRINGE AFTER PLACING THE CATHETER, SOME AIR CAME IN TO THE SYSTEM. BLOOD LEAKAGE WAS OBSERVED BETWEEN THE CATHETER AND CONNECTER. THE PHYSICIAN REMOVED AND REPLACED THE CATHETER TO COMPLETE THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6641400 ↗