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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
112 lots
Products Sold
112 lots
Biosense Webster, Inc. is recalling Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part due to Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026