Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date
Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with manufacturing defect (device disabled by firmware) and no reported adverse events, injuries, or deaths. Classified as Moderate because the defect prevents device functionality but does not pose a direct safety risk to patients.
Plain-English summary
Abbott is recalling 2,134 TactiCath Sensor Enabled Contact Force Ablation Catheters, Model A-TCSE-DF, because the devices were manufactured with a preprogrammed 'First Use Date' in the device firmware (EEPROM) that disables the device.
The affected devices include 37 specific lot numbers and were distributed in the United States and internationally to Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
Patients and healthcare providers should contact Abbott if they have these devices. Healthcare facilities should verify lot numbers of any TactiCath devices in their inventory and follow Abbott's instructions for device replacement or return.
The recalled product
- Product
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
- Manufacturer
- Abbott
- Affected units
- 2,134
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot numbers: 8162700
- 8164687
- 8164730
- 8172360
- 8173365
- 8173840
- 8175413
- 8177068
- 8177349
- 8177442
- 8179358
- 8179499
- 8180723
- 8180900
- 8181043
- 8182658
- 8183581
- 8183595
- 8184393
- 8184739
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Abbott under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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