Agency classClass IIOur severity:High FDA (Devices)·Z-2281-2021·Announced 2021-08-18

Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks

Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.

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: This is a Class II medical device recall for a risk-of-harm product without reported injuries or hospitalizations. Internal leaks in a pediatric oximetry catheter could compromise critical monitoring, warranting a High severity rating.

Plain-English summary

Edwards Lifesciences, LLC is recalling Edwards PediaSat Oximetry Catheter Sets (REF: XT358SP) due to a potential for internal leaks within the catheters. The affected product is a 5.5F pediatric oximetry catheter with a 9 cm usable length and 3 lumens.

Internal leaks within the catheters could compromise device function during clinical use. Patients and healthcare providers who have these devices should contact Edwards Lifesciences for information about affected units.

The recall involves 178 units with affected lot numbers 62685542, 63316354, 62704123, 62667413, and 63608316. Distribution includes multiple US states (California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, Ohio) and numerous international locations.

Adverse events or injuries related to this recall should be reported to Edwards Lifesciences or to the FDA through MedWatch.

The recalled product

Product: Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Pediatric Oximetry Catheter
Hazard: internal-leak
Affected units: 178

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: 62685542
62685542
63316354
62704123
62667413
63608316

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · internal leak