Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices
Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a critical medical device used in cardiac ablation procedures. No illnesses or injuries have been reported; however, the preprogrammed software disables device functionality, creating a risk of harm if non-functional devices are inadvertently used in patient procedures.
Plain-English summary
Abbott has recalled 588 TactiCath Sensor Enabled Contact Force Ablation Catheters, Model A-TCSE-DD, due to a manufacturing defect. The devices were preprogrammed in their memory (EEPROM) with a "First Use Date" that disables the functionality of the single-use catheter.
The recalled devices were distributed worldwide, including nationwide throughout the United States. International distribution included Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and the United Kingdom. Affected lot numbers are: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547.
The TactiCath is an ablation catheter used in cardiac electrophysiology procedures. Healthcare organizations should verify lot numbers of devices in inventory against the recalled lots to prevent use of non-functional devices.
The recalled product
- Product
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
- Manufacturer
- Abbott
- Hazard
- device-malfunction
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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).
Distribution
Distributed nationwide across the United States.
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