Device product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Z-0956-2022
Product summary
- Firm
- Abbott
- Event
- Event 89872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,134 devices
- Official record key
device-enforcement:Z-0956-2022
Official wording
Reason: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Code information: Lot numbers: 8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913. UDI (01)05415067027641(17)230331(10)xxxxxxx (lot number).
Distribution pattern: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
Derived failure modes
-
Unknown
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.