Abbott TactiFlex Ablation Catheter Recalled for Tip Detachment During Removal
Abbott is recalling approximately 85,803 TactiFlex Sensor Enabled Ablation Catheters due to tip detachment occurring during removal from packaging in a limited number of units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. Although no illnesses or injuries are reported in the source, the agency's determination of Class I status indicates a serious device defect requiring immediate corrective action.
Plain-English summary
Abbott is recalling approximately 85,803 units of the TactiFlex Sensor Enabled Ablation Catheter (8F, 115 cm, DF, BiD Curve D-F, REF A-TFSE-DF) due to tip detachment during packaging removal. The device is a cardiac ablation catheter used in heart procedures. The recall is issued as FDA Class I.
Abbott has identified a limited number of events where the catheter tip detaches during removal of the device from its packaging. This defect could affect the usability and safety of the device before it is used on a patient.
These catheters were distributed worldwide. Healthcare facilities using this catheter model should verify which units in their inventory are affected by checking batch numbers against the list provided in the FDA recall notice.
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
- Hazard
- tip-detachment
- device-malfunction
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.
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