Abbott recalls specific TactiCath Sensor Enabled Contact Force Ablation Catheters due to a preprogrammed First Use Date that disables single-use devices. Affected models include Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
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 TactiCath Sensor Enabled Contact Force Ablation Catheters 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 the date is reached, potentially leading to ineffective medical procedures.
The catheters were manufactured with a preprogrammed First Use Date in their internal memory. This date disables the device after the first use, making it unable to function properly for subsequent procedures. The hazard is limited to the specific model and lot numbers listed.
Medical professionals who use the recalled catheters for procedures are affected. Patients using these catheters during treatment may be at risk of ineffective procedures due to the device being disabled.
Check for the model number A-TCSE-DF on the catheter packaging or device. Look for lot numbers listed in the recall: 8162700, 8164687, 8164730, and other specific numbers provided in the recall notice.
Verify if the catheter has a preprogrammed First Use Date by checking the device's internal memory or packaging.
The catheters were manufactured with a preprogrammed First Use Date that disables the device after initial use, making them unable to function properly for subsequent procedures.
Check for the model number A-TCSE-DF and lot numbers listed in the recall: 8162700, 8164687, 8164730, and other specific numbers provided in the recall notice.
The recall does not specify a remedy, so contact Abbott directly for guidance on handling the device.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0956-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0956-2022 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.
