Agency classClass IIOur severity:High FDA (Devices)·Z-0146-2023·Announced 2022-11-09

Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration

Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a confirmed material integrity issue (latex deterioration) that poses a risk of device malfunction. No illnesses or injuries have been reported. Per the rubric, this qualifies as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Edwards Lifesciences, LLC is recalling Fogarty Arterial Embolectomy Catheters across multiple model numbers (120602FP, 120403FP, 120803FP, 120404FP, 120804FP, 120805FP, 120806FP, 120807FP, 120403FSP, 120803FSP). Approximately 715,620 units are affected by this recall.

The catheters are being recalled due to an increase in confirmed latex deterioration complaints. The deterioration occurs in catheters packaged in pouches and could compromise device integrity and function.

The recalled catheters were distributed worldwide, including throughout all U.S. states and territories, as well as to numerous international markets. Healthcare facilities and physicians who have received these catheters should discontinue use of affected lot numbers and contact Edwards Lifesciences for replacement or guidance.

Patients and healthcare providers with questions about whether they have affected devices should contact Edwards Lifesciences or consult with their physician.

The recalled product

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
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Vascular Surgery
Hazard: latex-deterioration
device-failure
Affected units: 715,620

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · latex deterioration