FDA Medical Device Recalls (openFDA)
Abbott: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
- Recall number
- Z-0957-2022
- Recalling firm
- Abbott
- Product
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
- Status
- Open, Classified
- Initiated
- 2022-03-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
- 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
- 588 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.
- Lot, serial or model codes
- Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).
- 510(k) numbers
- not on file
- PMA numbers
- ["P130026"]
- Product code
- OAE
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28