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Terminated

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.

FDA Recall Z-1437-04 · Posted 2004-09-02

Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDRF
Date Initiated2004-08-16
Date Terminated2005-03-31
Product Quantity848

Reason for Recall

Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Japan, Europe, & Uruguay

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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