Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0956-2022 — Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

U.S. FDA — Device Enforcement · United States · 2022-03-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0956-2022
Date of alert
2022-03-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05415067027641
Reported risk: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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