SWAN-GANZ TRUE SIZE 132F5Recalls & reported problems
Edwards Lifesciences LLC · SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER · Class 2
All models of SWAN-GANZ TRUE SIZE (8)
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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 18, 2026.
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 ↗
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 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly det
- Z-0764-2019 · Dec 21, 2018 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly de
- Z-0765-2019 · Dec 21, 2018 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly dete
- Z-0763-2019 · Dec 21, 2018 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians
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
- 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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