Recall Z-0580-2015— Boston Scientific Corp

Name: FDA recall Z-0580-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-20

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corp, initiated 2014-11-20, terminated 2016-08-11. It names one FDA 510(k) clearance: K122461. Product: 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: 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..

Recalling firm: Boston Scientific Corp
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Terminated: 2016-08-11
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122461 — RHYTHMIA MAPPING CATHETERRhythmia Medical, Inc.·cleared 2013-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.