Recall Z-0057-06 ยท LPB Cardiac Ablation Percutaneous Catheter
Biosense Webster, Inc.
Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71
| Date | Oct 15, 2005 (initiated Aug 8, 2005) |
| Status | Terminated |
| Reason | Increased complaints regarding catheters with leaks and flow obstruction. |
| Root cause | Other |
| Action | Urgent letters and response forms dated August 8, 2005 directed consignees to return product. |
| Quantity | 9,679 |
| Distribution | FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand, China, Hong Kong, Singapore, Pakistan, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.