Abbott SE TactiCath Sensor Enabled Contact Force recall
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Why was Abbott SE TactiCath Sensor Enabled Contact Force recalled?
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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).
- Product
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
- Recalling firm
- Abbott
- Quantity
- 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.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)