Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S
FDA device recall Z-1437-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
- Action taken
- Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 848
- Distribution
- Nationwide and Japan, Europe, & Uruguay
- Date initiated
- 2004-08-16
- Date posted
- 2004-09-02
- Date terminated
- 2005-03-31
- Location
- Irwindale, CA
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