Swan-Ganz AIQSGF8Recalls & reported problems
Edwards Lifesciences LLC · Swan-Ganz IQ Pulmonary Arterial Catheter · Class 2
All models of SWAN-GANZ (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103217094), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Apr 8, 2026Class IIOpen, 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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860162 ↗
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 · each recall links to the FDA recall notice
- 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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