Edwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error
Edwards Lifesciences is recalling specific Fogarty Adherent Clot Catheters because the balloon diameter measures 6mm instead of the intended 10mm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. No injuries or illnesses are reported in the source text, and the defect is a dimensional error rather than a contamination or structural failure leading to immediate harm.
Plain-English summary
Edwards Lifesciences, LLC is recalling 200 units of Fogarty Adherent Clot Catheters, Model Numbers 1408010 and 140806. The recall involves Lots 60439817 and 60439818. These medical devices are designed to remove clot material from the peripheral vasculature, specifically indicated for the removal of emboli and thrombi from native arteries or synthetic grafts.
The reason for the recall is that the diameter of the Fogarty Catheter balloon measures 6mm instead of the intended 10mm. This discrepancy in the balloon size may affect the device's ability to effectively remove clot material as designed.
The affected units were distributed worldwide, including the United States and several European countries such as the United Kingdom, Netherlands, Germany, Italy, France, Belgium, Spain, Norway, Czech Republic, Bulgaria, Sweden, Austria, Switzerland, Poland, Russia, and Finland. Healthcare providers and patients who have used or possess these specific model numbers and lot numbers should contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native art
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 60439817 and 60439818
Distribution
Distributed nationwide across the United States.
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