Z-0580-2015Class II

IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is...

Name: Z-0580-2015 IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is...
Creator: Boston Scientific Corp
Published: 2014-11-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-11-20 / Terminated / root cause: design

FDA source

Boston Scientific Corp began a recall of IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording... on 2014-11-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0580-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2014-12-10
Terminated: 2016-08-11
Recalling firm: Boston Scientific Corporation
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.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0580-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0580-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-10

Product code DRF

K122461Class IIRhythmia Mapping CatheterRhythmia Medical, Inc. / cleared 2013-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)