Curve D-F ablation catheters recalled after tip detachment from packaging
Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
TactiFlex Sensor Enabled Ablation Catheters, 8F, 115 cm, BiD Curve D-F, REF A-TFSE-DF, are being recalled.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recall covers 85,803 units carrying GTIN 05415067034571, across batch numbers including 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724 and 8948407. Distribution was worldwide. The FDA has classified the recall as Class I.
Electrophysiology labs should inspect the catheter before use and follow Abbott's instructions for affected batch numbers.
The recalled product
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
- Manufacturer
- Abbott
- Affected units
- 85,803
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 05415067034571
- Batch Numbers: 8707463
- 8728375
- 8848814
- 8849428
- 8856153
- 8859777
- 8930724
- 8948407
- 9085267
- 9134878
- 9139151
- 9151701
- 9154571
- 9170156
- 9172378
- 9202684
- 10005870
- 10014420
- 10014422
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Abbott under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Abbott
See all →- ModerateAbbott Recalls Amplatzer Amulet Left Atrial Appendage Occluder Devices
FDA (Devices) · 2026-10-28
- SevereCurve F-J ablation catheters recalled after tip detachment during unpacking
FDA (Devices) · 2025-10-22
- CriticalUniD curve F ablation catheters recalled after tip detachment from packaging
FDA (Devices) · 2025-10-22
- CriticalCurve D-D ablation catheters recalled after tip detachment from packaging
FDA (Devices) · 2025-10-22
- CriticalUniD curve ablation catheters recalled after tip detachment from packaging
FDA (Devices) · 2025-10-22
Same hazard · tip detachment
See all →- HighLarger nasal feeding tubes recalled because distal tips may detach
FDA (Devices) · 2025-10-15
- HighNasal feeding tubes recalled because distal tips may detach too easily
FDA (Devices) · 2025-10-15
- HighShorter 6 French feeding tubes recalled because distal tips may detach
FDA (Devices) · 2025-10-15
Similar recalls
- HighTactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System
FDA (Devices) · 2024-01-31
- ModerateAbbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date
FDA (Devices) · 2022-04-27
- HighAbbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss
FDA (Devices) · 2020-07-15
- HighAbbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices
FDA (Devices) · 2022-04-27
- HighAbbott TactiCath Ablation Catheter System Error Display Malfunction
FDA (Devices) · 2022-07-13
- HighBoston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
FDA (Devices) · 2014-06-25