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St. Jude Medical, Atrial Fibrillation Division, Inc. recall records

1 reported ongoing

1 records in this archive. Latest source date Dec 18, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do n...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KS, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX,...

Official source

Reasons in these listed records

  • When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the dis...

These examples come from this result page and are not a ranking of every recall reason.

Checking St. Jude Medical, Atrial Fibrillation Division, Inc.

Is there a recall on st. jude medical, atrial fibrillation division, inc. right now?

This archive contains 1 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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