CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Fogarty Thru-Lumen Embolectomy Catheter recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheter. The recall was initiated on 7 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00690103043532, Lot: 64936927

Quantity recalled185

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-0238-2024
FDA event ID: 93172
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Sep 2023
FDA classified: 6 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

7 Sep 2023	Recall initiated by company
6 Nov 2023	Classified by FDA	+60 days
15 Nov 2023	Published in enforcement report	+9 days

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

Reason for recall

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Product as listed by the FDA

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Where it was distributed

OUS: Singapore, Taiwan, Canada

Questions about this recall

Why was it recalled?

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Which lots are affected?

UDI-DI: 00690103043532, Lot: 64936927

Where was it sold?

OUS: Singapore, Taiwan, Canada

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.

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