Fogarty Biliary Balloon Probes recalled for latex deterioration
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
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: FDA Class II recall for confirmed latex deterioration in medical devices used in cardiovascular procedures. The confirmed hazard status and risk of device malfunction warrant a High severity classification, though no injuries or hospitalizations have been reported.
Plain-English summary
Edwards Lifesciences is recalling three models of Fogarty Biliary Balloon Probes (model numbers 410235FP, 410405FP, and 410236FP). The recall affects approximately 26,560 units.
The FDA Class II recall was initiated following an increase in confirmed latex deterioration complaints. The deterioration occurs in devices packaged in pouches and could affect device integrity and function during use.
The devices have been distributed worldwide, including throughout all U.S. states and numerous international countries such as Canada, Australia, Japan, and many others. Multiple specific lot numbers have been identified across all three model numbers.
The recalled product
- Product
- Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 26,560
Distribution
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.
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