Quick Facts at a Glance
- Recall Date
- September 10, 2025
- Hazard Level
- HIGH
- Brand
- Abbott
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
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
- Ablation Catheter
- Model numbers
- A-TFSE-FJ, GTIN 05415067034618, Batch Numbers: 10093213, 10093588, 10095366, 10096269, 10118676, 10131389 +13 more
- Sizes
- 8F 115 cm
- Sold at
- Multiple Retailers
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
The TactiFlex Sensor Enabled Ablation Catheter is used in electrophysiology for cardiac tissue ablation. It is designed for catheter-based procedures.
Why This Is Dangerous
A limited number of tip detachment events have occurred during removal from packaging. A detached tip could pose a physical hazard during handling or subsequent use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using the affected devices may need to identify and replace lot-specific catheters. The recall could affect procedural scheduling and inventory management.
Practical Guidance
How to identify if yours is affected
- Confirm device model A-TFSE-FJ.
- Check GTIN 05415067034618 on the packaging.
Where to find product info
Look on the device packaging and labeling; recall notices from Abbott and FDA listing.
What timeline to expect
Refunds or replacements typically take 4-8 weeks.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Consult FDA advisories
- File a formal complaint with consumer protection authorities if needed
How to prevent similar issues
- Verify device model and batch numbers before procedures in the future
- Maintain updated recall communications in procurement records
- Work with suppliers to ensure only non-recalled lots are used
Documentation advice
Keep the recall notice, packaging, serial/batch numbers, photos, and correspondence with Abbott or distributors for records.
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Reported Incidents
Abbott reports a limited number of tip detachment events during packaging removal. No injuries or adverse patient events have been reported to date.
Key Facts
- Model A-TFSE-FJ includes BiD Curve F-J
- Batch numbers listed for verification
- Tip detachment during packaging removal
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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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