Z-0956-2022Class II

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

Name: Z-0956-2022 Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile
Creator: Abbott
Published: 2022-03-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-03-24 / Open, Classified / root cause: manufacturing process

FDA source

Abbott began a recall of Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile on 2022-03-24. FDA classified it as Class II and gives the reason as "Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0956-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-24
Posted: 2022-04-19
Recalling firm: Abbott Medical
Product: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Reason for recall: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2,134 devices
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 codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0956-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-19
Z-0957-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-19

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)