Agency classClass IIOur severity:High FDA (Devices)·Z-2194-2012·Announced 2012-08-22

Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Edwards Lifesciences, LLC is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters, Model 141HF7J. These medical devices are used for hemodynamic monitoring in patients. The recall covers units distributed worldwide, including the United States, Canada, Japan, EMEA, Asia Pacific, and Latin America.

The recall was initiated because the firm received multiple complaints regarding the passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. The affected product codes are 59194334, 59224788, 59239507, and 59247472.

Healthcare providers and facilities should stop using the affected catheters and contact Edwards Lifesciences for instructions on returning the devices. Patients who have had these catheters inserted should consult their healthcare provider if they have concerns about the device.

The recalled product

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Catheters
Hazard: device-malfunction
Affected units: 32,145

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 (4)

59194334
59224788
59239507
59247472

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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