CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report

Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Kit, distributed in 12 states. The recall was initiated on 9 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT NUMBERS: 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, 63374025

Quantity recalled218 UNITS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2280-2021
FDA event ID: 88270
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Jul 2021
FDA classified: 12 Aug 2021
Reported: 18 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

9 Jul 2021	Recall initiated by company
12 Aug 2021	Classified by FDA	+34 days
18 Aug 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for internal leaks within catheters.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US

Where it was distributed

US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada

Arizona California Florida Indiana Maryland Michigan New Jersey New York Ohio Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

There is a potential for internal leaks within catheters.

Which lots are affected?

LOT NUMBERS: 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, 63374025

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 88270

This product is part of a recall event; the main page for the event is Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences.

Reported	Class	Recall	Company	Reason	Where
18 Aug 2021	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021	CLASS II	Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021	CLASS II	Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states

More recalls from Edwards Lifesciences

All 95

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Other	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide