10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12… recallZ-1839-2011 · Biosense Webster, Inc. · initiated Feb 15, 2011
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1839-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 15, 2011
- Posted by the FDA
- Mar 28, 2011
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 606 units total
- Product code
- DQK
- FDA submissions
- K090017
- Distribution
- Nationwide Distribution - including GA, KY, NV, WA, PA, and UT
Product description
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.
Code information (models, lots, serial numbers)
Catalog Number D128709
Other devices under the same FDA submission
6 devices cleared under K090017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CARTO 3 FG540000Biosense Webster (Israel) Ltd. · Computer, diagnostic, programmable1 death437 reports
- Carto 3 CR3434CTBiosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE2 reports
- Carto 3 CB3410CTBiosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 report
- Carto 3 CB3412CTBiosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 report
- Carto 3 CB3434CTBiosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 report
- Carto 3 CY1212CTBiosense Webster Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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