Recall Z-0580-2015 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific Corp
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.
| Date | Dec 10, 2014 (initiated Nov 20, 2014) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 184 units |
| Distribution | Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122461 | RHYTHMIA MAPPING CATHETER Rhythmia Medical, Inc., Apr 18, 2013 |