CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D) recalled
Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D). The recall was initiated on 10 Sep 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0110-2026
- FDA event ID
- 97595
- Recalling firm
- Abbott, Plymouth, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Sep 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 10 Sep 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +30 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Which lots are affected?
GTIN 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917, 9003044, 9003047, 9012222, 9013428, 9015293, 9038354, 9039239, 9065946, 9066884, 9071294, 9119487, 9138236, 9147733, 9148411, 9156153, 9158891, 10162247, 10173398, 10205310, 10207502, 10218030, 10228449, 10228450, 10230429, 10232940, 10235434, 10235436, 10240235, 10242138, 10242992, 10242995, 10280672, 10288053, 10288057, 10289553, 10289668, 10289709, 10289759, 10297899, 10334695, 10334845, 10338853, 10338856, 10343551, 10360411, 10375524, 10382430, 10384530, 10384531, 10395601, 10395605, 10449220, 10451314, 10451768, 10451769, 10458698, 10465076, 10465083, 10465086, 10466761, 10469707, 10509213, 10565373, 10565827, 10566663, 10599493, 10600697, 10601488, 10610624, 10615028, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049, 10763071, 10765654, 10780658, 10780710, 10781495, 10781677, 10788527, 10792081, 10792406, 10792407, 10793780, 10799615, 10799616, 10805125, 10805367, 10805369, 10805370, 10805371, 10813353, 10834650, 10844788, 10850740, 10850746, 10851557, 10855920, 10855921, 10868920, 10868921, 10893531, 10978587, 10978588, 11017094, 11017095, 11034753.
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97595This product is part of a recall event; the main page for the event is TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled.
More recalls from Abbott
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | TactiFlex Sensor Enabled Ablation Catheter, 8F, DF, (BiD Curve D-F) recalled | Abbott | Packaging Defects | MN |
| Device | CLASS I | TactiFlex Sensor Enabled Ablation Catheter, 8F, F, (UniD Curve F) recalled | Abbott | Packaging Defects | MN |
| Device | CLASS I | TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled | Abbott | Packaging Defects | MN |
| Device | CLASS I | TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled | Abbott | Packaging Defects | MN |
| Device | CLASS II | Amplatzer TorqVue LP Catheter (Tvlpc) recalled by Abbott | Abbott | Other | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |