Recall Z-0956-2022— Abbott

Name: FDA recall Z-0956-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-24

Class II · Ongoing

Class II FDA medical device recall by Abbott, initiated 2022-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.. Reason: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device..

Recalling firm: Abbott
Classification: Class II
Status: Ongoing
Initiated: 2022-03-24
Firm location: Plymouth, MN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.