The Recall Desk
CriticalFDA (Devices)·Z-0112-2026·Announced 2025-10-22

Curve F-J ablation catheters recalled after tip detachment during unpacking

Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 F-J, REF A-TFSE-FJ, are being recalled.

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

The recall covers 11,810 units carrying GTIN 05415067034618, across batch numbers including 10093213, 10093588, 10095366, 10096269, 10118676, 10131389 and 10151333. 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, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Manufacturer
Abbott
Category
Medical Device — Cardiac catheter
Hazard
Affected units
11,810

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 05415067034618
  • Batch Numbers: 10093213
  • 10093588
  • 10095366
  • 10096269
  • 10118676
  • 10131389
  • 10151333
  • 10180969
  • 10286877
  • 10315661
  • 10317649
  • 10329929
  • 10332297
  • 10344177
  • 10350400
  • 10360030
  • 10374171
  • 10375844
  • 10418954

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

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Same hazard · tip detachment

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