Agency classClass IOur severity:Severe FDA (Devices)·Z-0762-2019·Announced 2019-02-06

Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

Edwards Lifesciences is recalling 277 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms."

Plain-English summary

Edwards Lifesciences, LLC is recalling 277 units of the Swan Ganz Thermodilution Catheter (REF131F 7J) due to a manufacturing defect. The affected products were distributed worldwide and include lot numbers 61321177 and 61227528.

The recall was initiated because the catheters have incorrect lumen assembly, which results in the reversal of the lumens. This defect causes the clinician to observe reversed pulmonary artery (PA) and central venous pressure (CVP) values and waveforms during use.

The Swan Ganz Thermodilution Catheter is a diagnostic tool used by physicians to determine hemodynamic pressures and cardiac output. Clinicians using these specific lots should verify their inventory against the provided lot numbers and contact the manufacturer for instructions on returning the affected devices.

The recalled product

Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J 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-labeling
incorrect-assembly
Affected units: 277

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: 61321177
61227528

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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