FDA-Device2020-04-29Class II

Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

Boston Scientific
Hazard

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Sold states
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Affected count
91 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2020

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