CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report
TactiFlex Ablation Sensor Enabled Ablation Catheter recalled
St. Jude Medical, Atrial Fibrillation Division is recalling TactiFlex Ablation Sensor Enabled Ablation Catheter, distributed nationwide in the US. The recall was initiated on 18 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0814-2024
- FDA event ID
- 93711
- Recalling firm
- St. Jude Medical, Atrial Fibrillation Division, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Dec 2023
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 18 Dec 2023 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +38 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 display and the catheter image may also appear inverted.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Where it was distributed
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, UT, VA, WA, and WV. The country of Canada.
Nationwide AlabamaArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisKansasMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontanaNorth CarolinaNebraska
Questions about this recall
Is TactiFlex Ablation Sensor Enabled Ablation Catheter recalled?
Yes. St. Jude Medical, Atrial Fibrillation Division recalled TactiFlex Ablation Sensor Enabled Ablation Catheter on 18 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-0814-2024.
Why was it recalled?
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 display and the catheter image may also appear inverted.
Which lots are affected?
Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.
Where was it sold?
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, UT, VA, WA, and WV. The country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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