Recall Z-0238-2024— Edwards Lifesciences, LLC

Name: FDA recall Z-0238-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-07

Class II · Ongoing

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2023-09-07. It names one FDA 510(k) clearance: K892410. Product: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35. Reason: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds)..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-09-07
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K892410 — FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERBaxter Healthcare Corp·cleared 1989-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.