Agency classClass IOur severity:Critical FDA (Devices)·Z-0764-2019·Announced 2019-02-06

Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

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 FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Edwards Lifesciences, LLC is recalling 9 units of the Swan Ganz Thermodilution Catheter, Reference 131VF7P, Lot Number 61176314. The recall is due to incorrect lumen assembly, which causes a reversal of the lumens. These catheters are used by physicians to determine hemodynamic pressures and cardiac output.

If the lumens are reversed, clinicians may observe reverse pulmonary artery (PA) and central venous pressure (CVP) values and waveforms. This defect may lead to inaccurate diagnostic readings during patient monitoring. The affected units were distributed worldwide.

The U.S. Food and Drug Administration has classified this recall as Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death. Healthcare providers should stop using the affected units and contact Edwards Lifesciences for further instructions.

The recalled product

Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P 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…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Catheter
Hazard: mis-assembly
inaccurate-reading
Affected units: 9

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 (1)

Lot Number: 61176314

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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Same hazard · mis assembly