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.
What this means for you
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
- Hazard
- latex-deterioration
- device-failure
Distribution
Distributed nationwide across the United States.
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