SWAN-GANZ TRUE SIZE 114F7Recalls & reported problems
Edwards Lifesciences LLC · TRUE SIZE MONITORING CATHETER TRIPLE LUMEN · Class 2
All models of SWAN-GANZ TRUE SIZE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103000313), received between Jun 26, 2025 and Jun 26, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, BEFORE USE IN PATIENT, THE BALLOON OF THIS SWAN-GANZ CATHETER LEAKED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS RUPTURED NEAR TO DISTAL BONDING SITE, THE EDGES OF BALLOON LATEX DID NOT APPEAR TO MATCH UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22334441 ↗
Other CATHETER, FLOW DIRECTED devices
- Graftmaster 1012580-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED30 deaths225 reports
- SWAN-GANZ CCOMBO V 777F8Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls92 reports
- Graftmaster 1012581-16Abbott Vascular Inc. · CATHETER, FLOW DIRECTED21 deaths147 reports
- SWAN-GANZ CCOMBO V 774F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls2 deaths41 reports
- Graftmaster 1012581-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED12 deaths135 reports
- Graftmaster 1012582-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths77 reports
- SWAN-GANZ VIP 831F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED1 recall23 reports
- Graftmaster 1012580-26Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths72 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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