CLASS II Device recall · Reported 27 Apr 2022 · FDA Enforcement Report

SE TactiCath Sensor Enabled Contact Force Ablation Catheter recalled

Abbott is recalling SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, distributed nationwide in the US. The recall was initiated on 24 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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).

Quantity recalled2,134 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0956-2022
FDA event ID: 89872
Recalling firm: Abbott, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2022
FDA classified: 19 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

24 Mar 2022	Recall initiated by company
19 Apr 2022	Classified by FDA	+26 days
27 Apr 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

Which lots are affected?

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).

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89872

This product is part of a recall event; the main page for the event is SE TactiCath Sensor Enabled Contact Force Ablation Catheter recalled.

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022	CLASS II	SE TactiCath Sensor Enabled Contact Force Ablation Catheter recalled	Abbott	Device Malfunction	Nationwide

More recalls from Abbott

All 20

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DF, (BiD Curve D-F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, F, (UniD Curve F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled	Abbott	Packaging Defects	MN

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