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.
This recall has been terminated (originally issued December 10, 2014).
- Company
- Boston Scientific Corp
- Recall Initiated
- November 20, 2014
- Posted
- December 10, 2014
- Terminated
- August 11, 2016
- Recall Number
- Z-0580-2015
- Quantity
- 184 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.