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Recall Observatory FDA recall evidence

Device product

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

Z-0957-2022

March 24, 2022

Class II

Product summary

Firm
Abbott
Event
Event 89872
Status
Ongoing
Classification
Class II
Quantity
588 devices
Official record key
device-enforcement:Z-0957-2022

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: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(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

    reason.no_named_rule · v1.0.0

    Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.