Agency classClass IOur severity:Severe FDA (Devices)·Z-0763-2019·Announced 2019-02-06

Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

Edwards Lifesciences is recalling 875 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a significant defect in a medical device that could lead to serious health consequences.

Plain-English summary

Edwards Lifesciences, LLC is recalling 875 units of Swan Ganz Thermodilution Catheters, reference 131F7P (5 pack of 131F7). The affected lot numbers are 61321241, 61176369, 61176374, 61311580, 61176373, and 61321254. The products were distributed worldwide.

The recall is due to incorrect lumen assembly, which causes a reversal of the lumens. If the lumens are reversed, clinicians may observe reverse pulmonary artery (PA) and central venous pressure (CVP) values and waveforms. This defect affects the diagnostic accuracy of the device, which is used to determine hemodynamic pressures and cardiac output.

Healthcare providers should stop using the affected catheters and contact Edwards Lifesciences for further instructions. The recall is classified as Class I by the FDA.

The recalled product

Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) 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…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Catheter
Hazard: mis-labeling
diagnostic-error
Affected units: 875

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 (6)

Lot Numbers: 61321241
61176369
61176374
61311580
61176373
61321254

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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