Home / Recalls / Boston Scientific Corp / Z-0580-2015

Z-0580-2015 Class II Terminated

Recalled by Boston Scientific Corp — San Jose, CA

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
November 20, 2014
Termination Date
August 11, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
184 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.

Code Information

Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, and 17308586. Expiry Dates from June 25, 2015 to September 24, 2015.

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