Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar
FDA device recall Z-3038-2011 · posted 2011-08-18 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number 0128709, through the J&J Gateway (i.e., e-IFU websi
- Action taken
- Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm. The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense. Customers with questions or require additionial information were instructed to contact their Biosense Webster representative.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 1530 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-04-29
- Date posted
- 2011-08-18
- Date terminated
- 2012-10-12
- Location
- Irwindale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER (K953768) | Cordis Webster, Inc. | 1995-11-22 |