Quick Facts at a Glance
- Recall Date
- September 10, 2025
- Hazard Level
- HIGH
- Brand
- Abbott
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abbott
- Product type
- Cardiac Catheter
- Model numbers
- GTIN 05415067034656, Batch Numbers: 8894231, 8915981, 9029640, 9255006, 10001631, 10053399, 10103653 +12 more
- Sizes
- 8F 115 cm
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 10, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott or your healthcare provider for instructions. Notification method: Letter
About This Product
TactiFlex sensors enable precise mapping during ablation procedures. Clinicians rely on these devices for cardiac interventions.
Why This Is Dangerous
Detachment of a catheter tip could complicate procedures and require additional intervention to recover the detached tip.
Industry Context
This recall is not part of a broader industry pattern to date.
Real-World Impact
Immediate clinical action required; impact primarily on healthcare providers and patients undergoing ablation.
Practical Guidance
How to identify if yours is affected
- Check model REF A-TFSE-D and GTIN 05415067034656.
- Confirm 8F, 115 cm length and UniD Curve D geometry.
Where to find product info
Recall notification letters from Abbott; the FDA recall page linked in the notice; device packaging and labeling.
What timeline to expect
Refunds/replacements follow Abbott recall processes, typically weeks to months.
If the manufacturer is unresponsive
- Escalate with hospital risk management
- Contact Abbott customer service for escalation
- File complaint with FDA if manufacturer unresponsive
How to prevent similar issues
- Verify device recall status before use in procedures
- Keep recall communications accessible for staff
Documentation advice
Maintain copy of recall notice, healthcare facility communication, and replacement records.
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Product Details
Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, UniD Curve D. REF A-TFSE-D. Category: Cardiac catheter. Quantity: 399 units. Distribution: Worldwide.
Reported Incidents
High hazard level with limited number of tip detachment events reported. No injuries or specific incident count provided in the supplied data.
Key Facts
- Class I recall
- Tip detachment during packaging removal
- Active recall as of 2025-09-10
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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