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FDA-Device2026-02-18Class I

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

Medline Industries, LP
Hazard
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Sold states
Distribution US nationwide.
Affected count
94
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2026

Original summary

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808 Distribution: Distribution US nationwide. Affected quantity: 94

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