Recall Z-0884-2011 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Biosense Webster, Inc.
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
| Date | Jan 7, 2011 (initiated Oct 5, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES Biosense Webster, Inc., Oct 13, 2009 |