Abbott recalls specific SE TactiCath Sensor Enabled Catheters due to preprogrammed first use date disabling single-use devices. Affected models include A-TCSE-DD with listed lot numbers.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Abbott is recalling certain SE Tact: Catheter models because they have a preprogrammed first use date that disables the device after initial use. This means the catheter cannot be used as intended once activated.
The catheter has a preprogrammed first use date stored in its electronic memory that automatically disables the device after the first use. This prevents the device from functioning properly for subsequent procedures, potentially leading to ineffective treatments.
Medical professionals using the specific Abbott SE TactiCath catheter models listed in the recall. Patients receiving procedures with these catheters may be at risk if the device is used incorrectly.
Check for the model number A-TCSE-DD on the catheter packaging or device. Look for lot numbers listed: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547.
Verify if the catheter has a preprogrammed first use date by checking the device's electronic memory.
The catheter was recalled because it has a preprogrammed first use date that disables the device after initial use, preventing it from functioning properly for subsequent procedures.
Check for the model number A-TCSE-DD and lot numbers listed: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0957-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0957-2022 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
