Z-0238-2024Class II

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Name: Z-0238-2024 Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Creator: Edwards Lifesciences, LLC
Published: 2023-09-07
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2023-09-07 / Open, Classified / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 on 2023-09-07. FDA classified it as Class II and gives the reason as "Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0238-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-07
Posted: 2023-11-06
Recalling firm: Edwards Lifesciences LLC
Product: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Product code: DXE Catheter, Embolectomy
Reason for recall: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 9/7/23, correction notices were sent to customers informing them to take the following actions: 2) Return affected devices. 3) Forward notice to any of your customers who have purchased the impacted devices. 3) Complete and return the acknowledgement form.
Quantity in commerce: 185
Distribution: OUS: Singapore, Taiwan, Canada
Product codes and lots: UDI-DI: 00690103043532, Lot: 64936927

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0238-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0238-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06

Product code DXE

K892410Class IIFogarty(r) Thru-Lumen Embolectomy CatheterBaxter Healthcare Corp / cleared 1989-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)