Z-2776-2016Class II

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2...

Name: Z-2776-2016 CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2...
Creator: Biosense Webster, Inc.
Published: 2016-08-15
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2016-08-15 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation... on 2016-08-15. FDA classified it as Class II and gives the reason as "Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2776-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Posted: 2016-09-09
Terminated: 2017-01-20
Recalling firm: Biosense Webster Inc
Product: CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved by the Biosense Webster, Inc.Technical Services Team. The letter informs the customers of the actions to be taken. Actions Requested on Your Part: 1. Read this Medical Device Correction notification carefully. 2. If a CARTO 3 System currently resides within your hospital, the system has been corrected, and you should ensure that you have received a Field Service Report that indicates the system is in order. For questions regarding this recall call 909-839-8500. 3. Review, complete, sign, and return the Acknowledgement Form in accordance with the instructions listed on the form. 4. In the future, if a CARTO 3 System is installed in your facility, you should only conduct a clinical procedure after you have received a Field Safety Report dated after the installation of the device indicating that the system is in order. 5. Maintain awareness of this notice and pass this notice on to anyone in your facility that needs to be informed. Customers with any questions are instructed to contact their Biosense Webster, Inc. sales representative.
Quantity in commerce: 338 units
Distribution: International Distribution to China, Hong Kong and Brazil.
Product codes and lots: V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528 V 4.3: 61053, 61054, 61059, 11701, 12664 V 2.3: 14218, 13208, 50203, 50531, 14718, 50573

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2776-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2776-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code DQK

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)