Z-1839-2011

10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09...

Name: Z-1839-2011 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09...
Creator: Biosense Webster, Inc.
Published: 2011-02-15
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2011-02-15 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect... on 2011-02-15. The reason FDA records is "The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12...". 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-1839-2011
Status: Terminated
Initiated: 2011-02-15
Posted: 2011-03-28
Terminated: 2012-05-07
Recalling firm: Biosense Webster Inc
Product: 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog number D128709, through the J&J Gateway (ie, e-IFU website).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated March 16, 2011, to all affected customers (via express mail). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed Acknowledgement Form to confirm that all customers who received the product have been notified accordingly of this concern. If customers have any questions or require additional information, they are to contact their BWI representative and return the Acknowledgement form to: Biosense Webster, Inc. l5715 Arrow Highway Irwindale, CA 91706 Attn: Recall Coordinator - Virgil Ellsworth Phone: (909) 839-8500 Fax Number: (909) 839-7207. For questions regarding this recall call 909-839-7207.
Quantity in commerce: 606 units total
Distribution: Nationwide Distribution - including GA, KY, NV, WA, PA, and UT
Product codes and lots: Catalog Number D128709

Product code DQK

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)