Agency classClass IOur severity:Critical FDA (Devices)·Z-0765-2019·Announced 2019-02-06

Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

Edwards Lifesciences, LLC is recalling 459 units of the Swan Ganz Thermodilution Catheter (REF 151F7) due to a manufacturing defect. The affected devices have incorrect lumen assembly, which results in the reversal of the lumens. This defect affects lot numbers 61176367 and 61176370, which were distributed worldwide.

The recall is necessary because the reversed lumens cause the clinician to observe reversed pulmonary artery (PA) and central venous pressure (CVP) values and waveforms. This error can compromise the accuracy of hemodynamic assessments, including pressure monitoring and cardiac output determination, which are critical for evaluating a patient's hemodynamic condition.

Healthcare facilities and providers who have received these specific lot numbers should stop using the affected catheters and contact Edwards Lifesciences for further instructions on replacement or return. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.

The recalled product

Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Catheter
Hazard: mis-labeling
diagnostic-error
Affected units: 459

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot Numbers: 61176367
61176370

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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