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U.S. Department of Health and Human Services

Class 2 Device Recall IntellaMap Orion High Resolution Mapping Catheter

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  Class 2 Device Recall IntellaMap Orion High Resolution Mapping Catheter see related information
Date Initiated by Firm November 20, 2014
Date Posted December 10, 2014
Recall Status1 Terminated 3 on August 11, 2016
Recall Number Z-0580-2015
Recall Event ID 69818
510(K)Number K122461  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
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.
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. 
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact Mark Lanz
763-494-2895
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 184 units
Distribution Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = RHYTHMIA MEDICAL, INC
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