Cook G02433Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002024335), received between Nov 16, 2016 and Sep 21, 2026 — classified as 2 injuries, 11 malfunctions.

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

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Unraveled Material

  Patient problems: Insufficient Information

  MAUDE report 50846084 ↗
• MalfunctionFeb 26, 2026Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A COOK LOCK PERICARDIOCENTESIS CATHETER SET WAS FOUND TO BE STRETCHED AND SEPARATED. 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 24455270 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED IN ADDITIONAL INFORMATION THAT NOTHING WAS ATTACHED TO THE DEVICE; THE DEVICE WAS TO BE USED BY ITSELF UNDER IMAGE GUIDANCE. PRIOR TO USING THE PRODUCT, AIR LEAKAGE WAS OBSERVED FROM THE HUB OF THE CATHETER, "THE PROXIMAL DISTAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638594 ↗
• MalfunctionOct 18, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A HAIR INSIDE A STERILE LOCK PERICARDIOCENTESIS CATHETER SET. NO PATIENT CONTACT WAS MADE.

  Patient problems: No Patient Involvement

  MAUDE report 9209242 ↗
• MalfunctionMar 25, 2019Material 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 Consequences Or Impact To Patient

  MAUDE report 8449664 ↗
• MalfunctionApr 23, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE (B)(4) DISTRIBUTOR REPORTED THAT BACK HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGE DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7450091 ↗
• MalfunctionApr 6, 2018Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE LOCK PERICARDIOCENTESIS CATHETER SET, DURING THE IMPLANT OF A PERICARDIAL DRAIN, WHEN RETRIEVING THE GUIDE, THERE WAS A SENSE OF RESISTANCE: IN FACT, THE GUIDE WAS UNRAVELED. THE DRAIN AND WIRE GUIDE WERE REMOVED AT THE SAME TIME BECAUSE OF THE RESISTANCE AND THEN ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. PER THE CUSTOMER, THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404233 ↗
• MalfunctionMar 28, 2018Break; Coiled; Material Frayed

  THE FOLLOWING INFORMATION WAS REPORTED: THE LOCK PERICARDIOCENTESIS CATHETER SET WAS USED. AS THE PHYSICIANS WERE PULLING THE WIRE OUT OF THE PIGTAIL CATHETER AFTER BEING PLACED IN THE CORRECT POSITION, THE WIRE BEGAN TO GET A THINNER CALIBER (FRAYED) AND COILED. PART OF THE WIRE BROKE. IT CONTINUED TO STRETCH AND THEY STOPPED WHEN THEY MET RESISTANCE AND FOUND PART OF THE WIRE BROKE. IT WAS BEING HELD TOGETHER BY THE SMALL THIN COILED WIRE. THEY OPTED TO REMOVE THE PIG TAIL CATHETER AND WIRE TO PLACE A NEW CHEST TUBE USING A NEW SET. A CHEST X-RAY WAS ALSO DONE TO CONFIRM PLACEMENT AND TO MAKE SURE NO FOREIGN BODY WAS FOUND INSIDE THE PATIENT. NO PARTS OF THE DEVICE REMAINED IN THE PATIENT. THERE WERE NO ADDITION AFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379110 ↗
• InjuryMar 28, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED DURING THE USE OF THE LOCK PERICARDIOCENTESIS CATHETER SET, USING THE SELDINGER TECHNIQUE FOR DRAIN PLACEMENT TO DRAIN FLUID IN LEFT LOWER QUADRANT. THE CUSTOMER STATED THEY NO THIS IS CONSIDERED AS OFF LABEL. THE STRAW COLORED FLUID WAS DRAINED ON FIRST PASS OF NEEDLE AT FIVE CENTIMETERS (CM). DILATION WAS DONE AND ALLOWED TO DRAINED CATHETER OVER WIRE. IT WAS REPORTED ON ATTEMPT TO REMOVE WIRE, THERE WAS SIGNIFICANT RESISTANCE NOTED AND THE WIRE APPEARED TO BE SHEARING. THE DRAIN WAS REMOVED COMPLETELY AND NO WIRE REMAINED IN SITU WAS CONFIRMED BY ABDOMINAL ULTRASOUND. IT WAS REPORTED THE PRODUCT WAS USED FOR THIS PROCEDURE MANY TIMES WITHOUT ADVERSE EFFECT, AND AGREED IT MAY HAVE BEEN USER ERROR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CUSTOMER REPORTED THE DEVICE IS AVAILABLE FOR RETURN, BUT HAS NOT BEEN RECEIVED FOR EVALUATION AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 7377264 ↗
• MalfunctionMar 28, 2018Unraveled Material

  THE COMPLAINANT REPORTED THAT THE PERICARDIAL DRAIN WAS USED AND THE GUIDE WIRE UNRAVELED (THE MESH DISASSEMBLED) DURING WITHDRAWAL. 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 7377065 ↗
• InjuryMar 27, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE USING A LOCK PERICARDIOCENTESIS CATHETER SET A PIECE BROKE OFF THE DEVICE AND THE DRAINAGE HAD TO BE REMOVED COMPLETELY FROM THE BODY; IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED FROM THE COIL WHICH ALLOWED THE COIL TO ELONGATE. THERE WERE NO OTHER ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

  Patient problems: No Code Available

  MAUDE report 7374418 ↗
• MalfunctionNov 30, 2017Material Frayed; Material Separation; Material Frayed; Material Separation

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE GUIDEWIRE IN THE LOCK PERICARDIOCENTESIS CATHETER SET WAS FRAYING AND HAS BROKEN DURING USE. THE WIRE WAS REMOVED, AND AN EXTENDED SCAN (IMAGING) CONFIRMED THAT NO PARTS OF THE PRODUCT REMAINED IN THE PATIENT. THE CUSTOMER CONFIRMED NO ADDITIONAL PATIENT CONSEQUENCES OCCURRED. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7072050 ↗
• MalfunctionNov 16, 2016Material Fragmentation; Material Fragmentation

  IT WAS REPORTED "AFTER SUCCESSFULLY INSERTING THE PIG TAIL ON THE FIRST ATTEMPT, THE PHYSICIAN MET RESISTANCE WHILE TRYING TO REMOVE THE WIRE. HE RETRACTED THE PIG TAIL SLIGHTLY AND THE WIRE WAS EASILY REMOVED. AT THIS POINT THE PIG TAIL WAS REMOVED. THE INTRODUCER NEEDLE WAS REPLACED IN THE ORIGINAL PUNCTURE SITE. THE PHYSICIAN REINTRODUCED THE WIRE AND PIGTAIL A SECOND TIME. THERE WAS NO RESISTANCE TO WIRE REMOVAL ON THE SECOND ATTEMPT. ONCE THE GUIDEWIRE WAS PULLED OUT, IT STARTED TO BREAK AND SHRED. PER CUSTOMER, THEY DO NOT BELIEVE ANY PORTION BROKE OFF OR SHREDDED OFF INSIDE THE PATIENT." 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 Known Impact Or Consequence To Patient

  MAUDE report 6106181 ↗