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Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Recalled April 27, 2022 · FDA recall Z-0957-2022 · Abbott
Hazard
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. · FDA Class II
Units
588 devices
Sold at
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.
Description
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Manufacturer(s)
Abbott
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →