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.
FDA Recall Z-0580-2015 · Posted 2014-12-10
Advertisement
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDRF
Date Initiated2014-11-20
Date Terminated2016-08-11
Product Quantity184 units
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.
Firm Action
Urgent Medical Device Recall Correction Notification letters were sent on November 19, 2014 by overnight delivery. The letter identified the affected product and the problem. Customers were asked to read the Notification completely and ensure that all users are aware. The letter provides users with steps to mitigate the risk in the event that the identified problem occurs. Customers were also asked to complete and return the Customer Acknowledgement Form. A local sales representative can answer questions regarding the Field Correction.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement