IntellaMap Orion High Resolution Mapping Catheter — Class II medical device recall Z-0580-2015
Terminated recall by Boston Scientific Corp, reported 2014-12-17, distributed in AL, MA, NC, OK. Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on
| Recall number | Z-0580-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corp, San Jose, CA, United States |
| Recall initiated | 2014-11-20 |
| Classified | 2014-12-10 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2016-08-11 |
| Distributed | AL, MA, NC, OK |
| Countries outside the US | DE, FR, GB |
| Quantity | 184 units |
| Lot numbers | 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, 17308586 |
| Model numbers | RC64S |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0580-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.