FDAOctober 6, 2022device
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
What to do
FDA enforcement status: Ongoing
Brands named
edwards lifesciencesedwards
UPCs
006901032051140069010320513800690103205121
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACodman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes n...2026-04-10
- FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO2026-03-27
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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