device · product 1 of 2
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
- Recall number
- Z-0956-2022
- Initiated
- March 24, 2022
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Abbott
- Quantity
- 2,134 devices
App-derived interpretation
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
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.