Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Check against the official notice below — it lists the full affected range.
Abbott is recalling 588 TactiCath Sensor Enabled Contact Force Ablation Catheters (Model A-TCSE-DD, Bi-D, Curve DD) because they were manufactured with a "First Use Date" preprogrammed into the device's memory that disables use of the single-use device. The affected devices were distributed worldwide, including throughout the United States and in Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and the United Kingdom.
The recall affects 13 lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Reason for recall: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. Distribution: 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. Quantity: 588 devices Lot/code info: Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.