FDA Device recall Z-0580-2015
IntellaMap Orion High Resolution Mapping Catheter
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of IntellaMap Orion High Resolution Mapping Catheter by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0580-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-20 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | AL, MA, NC, OK |
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.
Identifiers
| code_info | Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 172749…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0580-2015%22
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