TactiCath recallZ-0956-2022 · Abbott · initiated Mar 24, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
FDA root cause category: Process control
What the company is doing
The recalling firm issued letters dated 3/24/2022 on 3/24/22 via hand-delivery. The letters explained the issue, the impact and associated risks, and the steps to reduce risk. The steps included not using any of the remaining inventory of the affected lots listed in Appendix A, complete and return the accompanying Acknowledgment Form, and return all remaining unused affected devices to the recalling firm. The consignee is informed their Abbott representative can assist in returning these devices and obtaining replacements. The notice is to be forwarded to anyone within their organization who may need to be notified and a copy of the notice should be kept along with the completed Acknowledgment Form for their records.
Recall details
- Recall number
- Z-0956-2022
- Status
- Terminated
- Initiated by the company
- Mar 24, 2022
- Recalling firm
- Abbott
- Quantity
- 2,134 devices
- Product code
- OAE
- FDA submissions
- P130026
- Distribution
- Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
Product description
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Code information (models, lots, serial numbers)
Lot numbers: 8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913. UDI (01)05415067027641(17)230331(10)xxxxxxx (lot number).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TactiCath™ A-TCSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall23 deaths923 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89872).
- Z-0957-2022 · TerminatedAbbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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