FDA Medical devices recall ·
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0111-2026
- Date
- (initiated September 10, 2025)
- Company / brand
- Abbott
5050 Nathan Ln N, Plymouth, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 85803 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Why was it recalled?
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 10446371, 10466941, 10467483, 10472548, 10482323, 10486432, 10486543, 10487677, 10488850, 10491456, 10492740, 10492927, 10496142, 10496743, 10498367, 10500724, 10501641, 10504231, 10506843, 10506857, 10507585, 10508992, 10509062, 10509063, 10514720, 10520904, 10520905, 10522288, 10523178, 10530261, 10531569, 10531637, 10532991, 10534332, 10534333, 10534886, 10535195, 10536214, 10536994, 10537319, 10537748, 10541506, 10543275, 10543815, 10543854, 10543855, 10545989, 10545990, 10545991, 10546398, 10546400, 10546436, 10547866,
Distribution
Worldwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0111-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.