Z-0884-2011

CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT...

Name: Z-0884-2011 CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT...
Creator: Biosense Webster, Inc.
Published: 2010-10-05
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2010-10-05 / Terminated / root cause: design

FDA source

Biosense Webster, Inc. began a recall of CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a... on 2010-10-05. The reason FDA records is "When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor". 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-0884-2011
Status: Terminated
Initiated: 2010-10-05
Posted: 2011-01-07
Terminated: 2012-05-07
Recalling firm: Biosense Webster Inc
Product: CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Reason for recall: When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
Root cause tag: design
FDA root cause: Device Design
Action: Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.
Quantity in commerce: 1692
Distribution: Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.
Product codes and lots: Part Number: D-1286-18; Catalog Number CR3410CT

Product code DSA

K090017Class IICarto 3 Ep Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. / cleared 2009-10-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)