Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
FDA Recall Z-0639-05 · Posted 2005-03-18
Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeMTD
Date Initiated2005-02-14
Date Terminated2005-08-22
Product Quantity6694 units were distributed.
Reason for Recall
The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
Firm Action
All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures.
Root Cause
Other
Distribution Pattern
This product was distributed to 521 accounts worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K021232CONSTELLATION CATHETERS, MODEL 8031MBoston Scientific Corp · 2002-05-16K003782CONSTELLATION CATHETER, MODEL 8031Boston Scientific Corp · 2001-02-14K000277CONSTELLATION CATHETERSBoston Scientific Corp · 2000-09-26K992777CONSTELLATION CATHETERS, MODEL 8039Boston Scientific Corp · 1999-11-12K983171CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEMBoston Scientific Corp · 1999-03-11
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.