Recall Z-0057-2018
Biosense Webster, Inc. · initiated September 6, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Codes / lots: 17688816M, 17697930M, 17697966M
Reason for recall
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
FDA-determined cause: Under Investigation by firm
Action taken
All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS customer communication will occur in accordance with local regulations.
Details
- Recall number
- Z-0057-2018
- Initiated
- September 6, 2017
- Terminated
- November 19, 2019
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 19 units
- Distribution
- US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0054-2018 Class II | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0055-2018 Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0056-2018 Class II | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0058-2018 Class II | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-SBiosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |