FDA-Device2020-04-29Class II
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
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
225
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2020Don't want to check this manually?
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