Recall Z-0146-2023— Edwards Lifesciences, LLC

Name: FDA recall Z-0146-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-06

Class II · Ongoing

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2022-10-06. It names one FDA 510(k) clearance: K193379. Product: Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP. Reason: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-10-06
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC·cleared 2020-06-12

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 Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP

Reason for recall

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

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