SWAN-GANZ 110F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103000269), received between Apr 5, 2022 and Apr 5, 2022 — classified as 3 malfunctions.

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

• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THESE 3 SWAN-GANZ CATHETERS FROM THE SAME LOT NUMBER WERE OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015272 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THESE 2 SWAN-GANZ CATHETERS FROM THE SAME LOT NUMBER WERE OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015239 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THESE 2 SWAN-GANZ CATHETERS FROM THE SAME LOT NUMBER WERE OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015211 ↗