Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-0238-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Product Classification:

Class II

Date Initiated: September 7, 2023

Date Posted: November 15, 2023

Recall Number: Z-0238-2024

Event ID: 93172

Reason for Recall:

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

Status: Ongoing

Product Quantity: 185

Code Information:

UDI-DI: 00690103043532, Lot: 64936927

Distribution Pattern:

OUS: Singapore, Taiwan, Canada

Voluntary or Mandated:

Voluntary: Firm initiated