Agency classClass IIOur severity:High FDA (Devices)·Z-2278-2021·Announced 2021-08-18

Edwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks

Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.

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 (catheter with potential internal leak) where injury has not yet been reported. Per the severity rubric, such products are classified as High (score 3).

Plain-English summary

Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit, model REF: XT3515KTP (UDI: 00690103197563), due to a potential for internal leaks within the catheter. The affected product is an oximetry catheter with a 5.5F exterior diameter, 15 cm usable length, and 3 lumens, recommended for use with 0.025" guidewire. The recall involves lot numbers 63522902 and 63608320.

The recall affects 70 units that were distributed across the United States (California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, and Ohio) and internationally to Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Oman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, and Canada.

Healthcare providers and patients who have received this product should contact Edwards Lifesciences for further guidance regarding this recall.

The recalled product

Product: Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Catheter
Hazard: internal-leak
Affected units: 70

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 NUMBERS: 63522902 AND 63608320

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