Recall archive / FDA device enforcement
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter — FDA record Z-0111-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 10, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
- Reason
- Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Classification
- Class I
- Recalling firm
- Abbott
- Quantity
- 85803 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0111-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9134878, 9139151, 9151701, 9154571, 9170156, 9172378, 9202684, 10005870, 10014420, 10014422, 10035838, 10060049, 10067495, 10074488, 10093061, 10095119, 10133240, 10143719, 10146336, 10150246, 10150248, 10158750, 10163256, 10168649, 10175479, 10191672, 10206135, 10219459, 10246287, 10250075, 10259721, 10266993, 10268128, 10278549, 10278947, 10278998, 10279023, 10279962, 10282364, 10284613, 10286135, 10299761, 10301720, 10301724, 10302971, 10310965, 10313193, 10321650, 10321684, 10330213, 10334312, 10337388, 10343800, 10346421, 10347095, 10350600, 10356054, 10356057, 10358260, 10358261, 10358263, 10358912, 10359408, 10359726, 10364782, 10368136, 10369950, 10373269, 10383386, 10392552, 10398359, 10399262, 10399266, 10401107, 10401352, 10405601, 10406221, 10413503, 10419427, 10420466, 10423182, 10424553, 10429934, 10433340, 10441923, 10442325, 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10826290, 10826294, 1082767... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Sep 10, 2025
- Center classification date
- Oct 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.