FDA-Device2014-12-17Class II
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Boston Scientific Corp
Hazard
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Sold states
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
Affected count
184 units
Manufactured in
150 Baytech Dr, N/A, San Jose, CA, United States
Products
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2015Don't want to check this manually?
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