Abbott: Medical Device Recall in 2022 - (Recall #: Z-0957-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 24, 2022

Date Posted: April 27, 2022

Recall Number: Z-0957-2022

Event ID: 89872

Reason for Recall:

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

Status: Ongoing

Product Quantity: 588 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated