Quick Facts at a Glance
- Recall Date
- September 10, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- CRITICAL
- Brand
- Abbott
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 05415067034670, 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317 +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
The TactiFlex ablation catheter is used in cardiac electrophysiology procedures to treat arrhythmias by delivering energy to targeted tissue.
Why This Is Dangerous
If the catheter tip detaches during removal from packaging, it could cause injury or complicate the procedure.
Industry Context
This recall is not described as part of a broader industry pattern in the supplied information.
Real-World Impact
Hospitals must screen inventory, halt use of affected devices, and coordinate with Abbott for replacement or refunds. The recall may affect procedural scheduling and supply chains.
Practical Guidance
How to identify if yours is affected
- Check device label for REF A-TFSE-F
- Verify size 8F and length 115 cm
- Review batch numbers listed in the recall
Where to find product info
Recall details appear on the FDA enforcement page and the Abbott recall communications; packaging and labeling will show model identifiers and batch codes.
What timeline to expect
Recall processing and replacement or refunds may take several weeks; hospitals should plan accordingly.
If the manufacturer is unresponsive
- Escalate to hospital risk management and procurement
- File a report with the FDA recall portal if the manufacturer is unresponsive
How to prevent similar issues
- Source devices from authorized distributors only
- Inspect packaging integrity before use
- Monitor recall notices for all electrophysiology devices
Documentation advice
Keep copies of the recall notice, take photos of labels and batch codes, and log communications with Abbott and hospital procurement
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Product Details
Brand: Abbott Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, UniD Curve F Reference: REF A-TFSE-F Classification: Class I recall Quantity: 1,958 units Distribution: Worldwide Identifiers: GTIN 05415067034670; Batch Numbers 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567 Recall date: 2025-09-10 Status: ACTIVE Hazard: Tip detachment during catheter removal from packaging Hazard level: HIGH Recall URL: https://www.accessdata.fda.gov/scripts
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,958 units recalled worldwide
- Class I recall designation
- Tip detachment during packaging removal cited as hazard
- GTIN 05415067034670 included in identifiers
- REF A-TFSE-F with UniD Curve F and 8F 115 cm size referenced
- Recall date 2025-09-10; recall active
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Safety Guide
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