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-DD, GTIN 05415067034557, Batch 8843948, Batch 8855039, Batch 8906316, Batch 8913730, Batch 8921154, Batch 8922146 +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
TactiFlex Sensor Enabled Ablation Catheters are used in electrophysiology to perform cardiac ablation procedures. The 8F, 115 cm length with Bi-D curve is designed for navigating the heart during therapy.
Why This Is Dangerous
A detached tip during removal from packaging could remain in the device or be introduced into a patient, creating a risk during a procedure.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must review inventory and quarantine affected lots. The recall could cause procedural delays and procurement disruption while replacements are arranged.
Practical Guidance
How to identify if yours is affected
- Verify REF A-TFSE-DD and device specifications (8F, 115 cm, BiD Curve D-D).
- Check GTIN 05415067034557 on the device label.
Where to find product info
Recall notices and guidance may be found via Abbott and the FDA recall page linked in the notice.
What timeline to expect
Refunds or replacements are typically processed within weeks to months, depending on Abbott procedures and hospital inventory needs.
If the manufacturer is unresponsive
- Document all communications with Abbott and hospital procurement.
- Escalate to the FDA recall contact or MedWatch if there is no timely response.
- Consult hospital risk management for guidance on patient safety and documentation.
How to prevent similar issues
- Verify device recalls before procurement and use.
- Implement a packing and labeling review process to catch nonconforming lots before use.
- Maintain an up-to-date inventory of all cardiac catheters with batch-level traceability.
Documentation advice
Keep the recall notice, device labels showing REF, GTIN, and batch numbers, photos of packaging, and all correspondence related to the recall.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3,403 units recalled worldwide
- Tip detachment during packaging removal cited as hazard
- Class I recall; Hazard Level HIGH
- Model/ref: A-TFSE-DD; GTIN 05415067034557; multiple batch numbers
- Recall notice issued by Abbott with letter notification
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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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