[pending] TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac cat
Pending LLM rewrite. Source: FDA_DEVICE Z-0113-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recalled product
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Manufacturer
- Abbott
- Category
- Medical Device — Devices
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 (20)
- GTIN 05415067034670
- Batch Numbers: 8894357
- 8917490
- 8984945
- 10061309
- 10061314
- 10061316
- 10061317
- 10084510
- 10084518
- 10089968
- 10089971
- 10099711
- 10132013
- 10132015
- 10132017
- 10217367
- 10360478
- 10360488
- 10371567
Distribution
Distribution scope not specified by the agency.
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