Pulmonary Wedge Pressure Catheter 150075Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994733658), received between May 15, 2018 and Jun 13, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 18, 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.

• MalfunctionJun 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ONE MEDTRONIC PULMONARY WEDGE PRESSURE CATHETER WAS EXPIRED APPROXIMATELY THIRTEEN DAYS WHEN IT WAS USED IN THE PATIENT IN AN PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201661 ↗
• MalfunctionNov 18, 2022Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE TWO PULMONARY WEDGE PRESS (PWP) CATHETERS IN A NON CALCIFIED, NON TORTUOUS FEMORAL VEIN. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICES WERE REMOVED FROM THE PACKAGING AND PREPPED PER IFU WITH NO ISSUES. THE DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT THE FIRST PWP CATHETER WOULD NOT DEFLATE. THE DEVICE WAS PLACED AT THE FEMORAL VEIN AND THE BALLOON WOULD NOT DEFLATE WHEN ATTEMPTED TO. THE CATHETER WAS REMOVED AND THE SECOND PWP CATHETER WAS THEN ATTEMPTED TO BE USED. HOWEVER, THE SECOND DEVICE WOULD NOT INFLATE OUTSIDE OF THE BODY. THIS DEVICE NEVER WENT INTO THE PATIENT'S BODY. A THIRD PWP CATHETER WAS USED AND WORKED PROPERLY. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE FIRST DEVICE, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822980 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE 7F PULMONARY WEDGE PRESSURE (PWP) CATHETER. IT WAS REPORTED THAT FOLLOWING SUCCESSFUL IMPLANTATION OF A NON-MEDTRONIC PULMONARY ARTERY PRESSURE MONITORING SYSTEM IT WAS FOUND THAT THE RIGHT VENTRICLE HAD BEEN PERFORATED AND THE PATIENT HAD A PERICARDIAL EFFUSION. THE PATIENT BEGAN COMPLAINING OF BACK PAIN AND CHEST PAIN AND THE BLOOD PRESSURE BEGAN TO DROP. A COMPUTED TOMOGRAPHY (CT) SCAN AND ECHO WERE PERFORMED AND THE PERICARDIAL EFFUSION WAS IDENTIFIED. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED TO DRAIN THE EFFUSION. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT FOR MONITORING, BUT REMAINED UNSTABLE. THE PATIENT WAS TAKEN FOR OPEN HEART SURGERY TO ASSESS/REPAIR THE SOURCE OF THE PERICARDIAL EFFUSION. THE PERFORATION INJURY IN THE RIGHT VENTRICLE WAS FOUND AND SUCCESSFULLY REPAIRED. IT WAS DETAILED THAT IT COULD NOT BE CONFIRMED IF THE PERFORATION WAS CAUSED BY THE MEDTRONIC PWP CATHETER OR BY THE GUIDEWIRE USED IN THE INITIAL PROCEDURE. IT WAS BELIEVED THAT IT WAS NOT CAUSED BY THE NON-MEDTRONIC PULMONARY ARTERY PRESSURE MONITORING SYSTEM DUE TO THE LOCATION OF THE PERFORATION IN THE RIGHT VENTRICLE. NO FURTHER PATIENT INJURY WAS REPORTED A

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Chest Pain; Insufficient Information; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 15672764 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT HEART CATHERIZATION PROCEDURE AN ATTEMPT WAS MADE TO INSERT A 7F PULMONARY WEDGE PRESSURE CATHETER IN THE LEFT PULMONARY ARTERY. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. NO ALLEGED PRODUCT ISSUE OCCURRED HOWEVER, IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE HEMOPTYSIS, A CONFIRMED RUPTURE OF THE PULMONARY ARTERY, AND RESPIRATORY / CARDIAC ARREST. AN ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) PROTOCOL AND MASSIVE TRANSFUSION WERE INITIATED. AN URGENT EMBOLIC COILING ENSUED AND PATIENT WAS INTUBATED. AN AORTIC BALLOON PUMP AND AN EPINEPHRINE DRIP WERE IN PLACE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Cardiac Arrest; Hemoptysis; Rupture

  MAUDE report 15146454 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PWP CATHETER WAS ATTEMPTED TO BE USED DURING A RHC PROCEDURE FOR IMPLANT OF A NON-MEDTRONIC DEVICE. IT WAS REPORTED THAT MOVEMENT OF THE PWP DEVICE CAUSED A HEART BLOCK. THE PATIENT RECEIVED ATROPINE AND THE ISSUE RESOLVED WITHOUT ANY FURTHER INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 10605550 ↗
• MalfunctionMar 20, 2020Burst Container or Vessel; Burst Container or Vessel

  THREE PULMONARY WEDGE PRESSURE CATHETER WERE ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A NON TORTUOUS, NON CALCIFIED VEINOUS SYSTEM IN THE RIGHT HEARTH CATH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICES WERE REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO FLOAT THE PULMONARY WEDGE PRESSURE CATHETER WITH THE BALLOON INFLATED THROUGH A PREVIOUSLY IMPLANTED VENOUS STENT AND THE STENT STRUTS BURST THE BALLOON. THE PROCEDURE WAS COMPLETE BY PASSING ANOTHER PULMONARY WEDGE PRESSURE CATHETER UNINFLATED THROUGH THE STENT. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE CATHETERS THAT HAD THE RUPTURED BALLOONS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859268 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 7F PULMONARY ARTERY WEDGE PRESSURE CATHETER WAS USED DURING A PROCEDURE. THERE WAS NO DAMAGE ON THE CATHETER WHEN IT WAS REMOVED. THE BALLOON WAS INFLATED AND THE CATHETER WAS IN GOOD WORKING CONDITION. IT IS INDICATED THAT A DISSECTION OCCURRED IN THE DISTAL LEFT PULMONARY ARTERY, FROM THE BALLOON ON THE CATHETER TIP BOBBING IN AND OUT OF THE PULMONARY ARTERY. THIS LED TO HEMOPTYSIS AND INTUBATION, AND IT WAS NECESSARY TO MOVE THE PATIENT TO ANOTHER FACILITY. THE PATIENT WAS STABILIZED, SPENT SEVERAL DAYS IN A REHAB FACILITY AND WAS DISCHARGED APPROX 8 DAYS AFTER THE INITIAL PROCEDURE.

  Patient problems: Aortic Dissection; Hemoptysis

  MAUDE report 7513557 ↗