SWAN-GANZ CONTROLCATH C146F7Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00690103153132), received between Feb 6, 2020 and Aug 8, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K160084); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 8, 2026Open, Classified

   Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

   Z-2202-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE AND DYSPNEA. PROCEDURE: HEART CATHETERIZATION. THERE WAS NO SYRINGE WITH THE SWAN PACKAGE. ANOTHER SYRINGE ATTEMPTED TO BE USED BUT THE BALLOON WILL NOT REMAIN INFLATED. ANOTHER SWAN HAD TO BE OPENED FOR THE SYRINGE. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Dyspnea

  MAUDE report 19937540 ↗
• MalfunctionApr 14, 2023Burst Container or Vessel

  EARLY 50¿S YEAR OLD FEMALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. DURING THE RIGHT HEART PROCEDURE, THE BALLOON AT THE END OF THE CATHETER BURST. ANOTHER SWAN USED WITHOUT FURTHER DIFFICULTY. NO KNOWN HARM TO PATIENT. THIS IS #15 REPORT FOR THE SAME PRODUCT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROL CATH (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742442 ↗
• MalfunctionFeb 9, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A LATEX FREE SWAN GANZ MODEL C146F7, LOT 64582597 BALLOON DEVELOPED A LEAK WHICH WAS NOTED AFTER THE ADVANCED PROVIDERS WERE UNABLE TO DEFLATE AIR FROM THE BALLOON WHILE ADVANCING THE SWAN THROUGH THE RIGHT VENTRICLE TO THE PULMONARY ARTERY. A STAT X-RAY WAS ORDERED, AND A CARDIOLOGY CONSULTATION WAS PLACED. UNDER SURGEON ADVISEMENT, THE SWAN WAS WITHDRAWN, WHERE IT WAS DISCOVERED THAT THE BALLOON WAS ACTIVELY LEAKING AIR. PATIENT DEMOGRAPHICS PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335734 ↗
• MalfunctionFeb 8, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A WHILE PREPPING A LATEX-FREE SWAN-GANZ, MODEL C146F7, LOT 64582597, THE BALLOON DID NOT COMPLETELY DEFLATE, AND WAS THEREFORE DETERMINED TO BE UNSAFE TO FLOAT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324128 ↗
• MalfunctionSep 23, 2022Material Rupture

  MID 70¿S FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE AND LATEX ALLERGY. PROCEDURE: LEFT AND RIGHT HEART CATHETERIZATION. SWAN PLACED IN FEMORAL VEIN FOR PRESSURE MEASUREMENTS, BALLOON RUPTURED BEFORE CATHETER ADVANCED INTO HEART. SWAN REMOVED WITHOUT KNOWN HARM TO PATIENT, DISCHARGED THE SAME DAY. THIS IS REPORT #14 FOR THE LF SWAN BALLOON BREAKAGE. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469996 ↗
• MalfunctionMar 22, 2022Break; Deflation Problem; Material Rupture

  ELDERLY FEMALE WITH LATEX ALLERGY HAVE A RIGHT HEART CATH. LATEX FREE SWANN BROKE WHILE IT WAS IN THE PATIENT. PHYSICIAN HAD THE BALLOON IN THE PATIENT AND THEN IT LOST AIR. SWANN REMOVED WITHOUT KNOWN INJURY AND ANOTHER ONE WAS USED SUCCESSFULLY. PLEASE NOTE THAT THIS IS #13 REPORTED FOR THE SAME PRODUCT, SAME BALLOON RUPTURE. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13844675 ↗
• MalfunctionMar 11, 2022Material Rupture

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE (CAD), HYPERTENSION (HTN) AND ATRIAL FIBRILLATION (A FIB). PROCEDURE: HEART CATH FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) EVALUATION. WHILE HAVING THE HEART CATH, THE BALLOON OF THE LATEX FREE SWAN RUPTURED. DEVICE REMOVED AND ANOTHER ONE USED. MINOR DELAY IN PROCEDURE, NO KNOWN HARM TO THE PATIENT, DISCHARGED THE SAME DAY. PLEASE NOTE THAT THIS IS #12 LATEX FREE SWANS THAT HAVE BEEN REPORTED FROM THIS FACILITY. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: Insufficient Information

  MAUDE report 13731827 ↗
• MalfunctionDec 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE IS SOME TYPE OF A METAL PIECE ON THIS CATHETER CLOSE TO THE THE PROXIMAL PORT THAT IS COMING OFF. THIS SHORT PIECE OF METAL BECAME DISLODGED AND WAS MOVING UNDER FLUORO. THE CATHETER WAS THEN REMOVED AND CUT OPEN, AND THE SAME TYPE OF WIRE MATERIAL WAS REMOVED. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921381 ↗
• MalfunctionNov 24, 2021Material Rupture

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION. PROCEDURE: RIGHT AND LEFT DIAGNOSTIC HEART CATHETERIZATION. LATEX FREE SWAN USED FOR PROCEDURE AND IT RUPTURED. IT WAS REMOVED INTACT, AND ANOTHER LATEX FREE SWAN USED FOR PROCEDURE. IT RUPTURED AS WELL. #3 LATEX FREE SWAN WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO KNOWN HARM TO PATIENT - PATIENT DISCHARGED THE SAME DAY. PLEASE NOTE THAT THIS IS #10 AND #11 OF THE LATEX FREE SWANS REPORTED THAT THE BALLOONS BROKE. 2021-8058, 2021-8085,2021-8110,2021-8008,2021-8009, 2021-8014, 2021-8022,2021-8050,2021-8052,20-8902 MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER) WILL OBTAIN. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, SWAN-GANZ CONTROLCATH (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868390 ↗
• MalfunctionOct 13, 2021Material Rupture

  A PATIENT WITH HISTORY OF CORONARY ARTERY DISEASE, POST ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND STENT PLACEMENT WAS ADMITTED DUE TO RECENT CHEST PAIN AND SHORTNESS OF BREATH. PATIENT UNDERWENT A HEART CATHETERIZATION AND THE BALLOON, FROM THE EDWARDS LIFESCIENCES SWAN-GANZ CONTROLCATH CATHETER, RUPTURED INSIDE THE PATIENT. THE BALLOON WAS REMOVED INTACT WITHOUT KNOWN HARM.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 12623165 ↗
• MalfunctionSep 10, 2021Inflation Problem

  PATIENT WITH HISTORY OF CORONARY HEART DISEASE, HYPERTENSION, RECENT CHEST PRESSURE AND SHORTNESS OF BREATH WAS ADMITTED FOR A RIGHT/LEFT HEART CATHETERIZATION WITH ANGIOPLASTY. THE LATEX FREE SWAN BALLOON OF THE SWAN-GANZ PULMONARY ARTERY CATHETER WOULD NOT STAY INFLATED. THE SWAN-GANZ PULMONARY ARTERY CATHETER WAS REMOVED FROM PATIENT WITHOUT KNOWN HARM, AND A DIFFERENT ONE WAS USED WITHOUT PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 12452498 ↗
• MalfunctionApr 27, 2021Burst Container or Vessel

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, DIABETES, AND ASTHMA. ADMITTED FOR SHORTNESS OF BREATH, PROCEDURE RIGHT AND LEFT HEART CATHETERIZATION. EDWARDS REPRESENTATIVE WAS PRESENT TO OBSERVE AND HER RECOMMENDATION WAS TO USE AN 8.5F SHEATH. AN 8.5F SHEATH WAS USED AND THE LATEX FREE SWAN BALLOON BURST. DEVICE REMOVED IN ITS ENTIRETY AND NO KNOWN HARM TO PATIENT. TYPICALLY, THE SURGEONS USE A 7F SHEATH (THEIR PREFERENCE) AND ON THE DEVICE PACKAGING IT RECOMMENDS USING AN 8.5F SHEATH. 8.5F SHEATH WAS USED FOR PROCEDURE AND BALLOON OF SWAN BROKE. THIS IS THE 7TH LATEX FREE SWAN BALLOON THAT BURST. INVASIVE HEART CATHETER LAB, CARDIOVASCULAR OPERATING ROOM, AND PURCHASING WERE INFORMED OF LOT NUMBERS FROM ALL 7 INSTANCES THE BALLOON BROKE.

  Patient problems: Dyspnea

  MAUDE report 11731721 ↗
• MalfunctionApr 8, 2021Material Rupture

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, STAGE III CHRONIC KIDNEY DISEASE AND RECENT CHEST PAIN AND SHORTNESS OF BREATH. WHILE HAVING A DIAGNOSTIC HEART CATH, THE BALLOON OF THE SWAN RUPTURED AND WAS REMOVED INTACT. A NEW SWAN WAS INSERTED, WITHOUT KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633425 ↗
• MalfunctionMar 2, 2021Material Rupture

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION AND CORONARY ARTERY DISEASE. ADMITTED WITH INCREASED SHORTNESS OF BREATH. WHILE HAVING A CARDIAC CATHETERIZATION, THE EDWARDS SWAN BALLOON RUPTURED WHILE IN THE PATIENT. NO KNOWN HARM TO PATIENT, PRODUCT REMOVED, AND NEW DEVICE USED.

  Patient problems: Dyspnea

  MAUDE report 11398437 ↗
• MalfunctionDec 8, 2020Break

  (B)(6) FEMALE FOR DIAGNOSTIC CATH. IN ATTEMPTING TO PASS AND INFLATE THE LATEX FREE SWAN, THE BALLOON BROKE. REMOVED INTACT WITHOUT KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10966943 ↗
• MalfunctionFeb 6, 2020Break; Material Puncture/Hole

  ELDERLY MALE WITH HISTORY OF SHORTNESS OF BREATH, HAVING HEART CATHETERIZATION."BALLOON ON SWAN GANZ CATHETER TESTED FINE UPON OPENING, ONCE INSIDE PATIENT, BALLOON BROKE". BALLOON REMOVED INTACT, PIN HOLE OBSERVED UPON REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 9675957 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160084. One submission often covers many models, so check the product and lot details in each record.

• Z-0762-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determ
• Z-0763-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians
• Z-0765-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determi
• Z-0764-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly deter