FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
- Recall number
- Z-1437-04
- Recalling firm
- Biosense Webster, Inc.
- Product
- Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
- Status
- Terminated
- Initiated
- 2004-08-16
- Posted
- 2004-09-02
- Terminated
- 2005-03-31
- Reason
- Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
- Root cause
- Other
- Action
- 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.
- Quantity
- 848
- Distribution
- Nationwide and Japan, Europe, & Uruguay
- Lot, serial or model codes
- 112 lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 3003113629
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28