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U.S. Department of Health and Human Services

Class 2 Device Recall Celsius Thermocool products and Navistar Thermocool products

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  Class 2 Device Recall Celsius Thermocool products and Navistar Thermocool products see related information
Date Initiated by Firm August 08, 2005
Date Posted October 15, 2005
Recall Status1 Terminated 3 on May 23, 2008
Recall Number Z-0057-06
Recall Event ID 32925
PMA Number P030031 
Product Classification Cardiac Ablation Percutaneous Catheter - Product Code LPB
Product 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 D71TFL252RT 35R-53R EXPORT;
L-1192-15-S D71TB5L252RT 35R-17R EXPORT;
L-1192-16-S D7ITD5L252RT 35R-37R EXPORT;
L-1189-02-SI D17TCDLRTI N/A IDE;
L-1189-15-SI D71TCB5L252RTI N/A IDE;
L-1189-16-SI D71TCD5L252RTI N/A IDE;
L-1189-17-SI D71CF5L252RTI N/A IDE

Navistar
LABEL US Part Number# EU CATALOG #
L-1192-17-S D71TF5L252RT 35R-57R EXPORT;
L-1197-14-S NI75TCBH 34H-17M PMA;
L-1197-15-S NI75TCCH 34H-27M PMA;
L-1197-16-S NI75TCDH 34H-37M PMA;
L-1197-17-S NI75TCFH 34H-57M PMA;
L-1197-18-S NI75TCJH 34H-J7M PMA;
L-1208-05-S NS75TBCT252HS 34G-17M PMA;
L-1208-06-S NS75TCCT252HS 34G-27M PMA;
L-1208-07-S NS75TDCT252HS 34G-37M PMA;
L-1208-08-S NS75TFCT252HS 34G-57M PMA;
L-1197-14-SI NI75TCBHI N/A IDE;
L-1197-15-SI NI75TCCHI N/A IDE;
L-1197-16-SI NI75TCDHI N/A IDE;
L-1197-17-SI NI75TCFHI N/A IDE;
L-1197-18-SI NI75TCJHI N/A IDE;
L-1208-05-SI NS75TBCT252HSI N/A IDE;
L-1208-06-SI NS75TCCT252HSI N/A IDE;
L-1208-07-SI NS75TDCT252HSI N/A IDE;
L-1208-08-SI NS75TFCT252HSI N/A IDE
Code Information Lots 13027030 to 13044734
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Mary McDermott
909-839-8720
Manufacturer Reason
for Recall		 Increased complaints regarding catheters with leaks and flow obstruction.
FDA Determined
Cause 2		 Other
Action Urgent letters and response forms dated August 8, 2005 directed consignees to return product.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPB and Original Applicant = BIOSENSE WEBSTER, INC.
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