TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Summary
The FDA issued a Class II for TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F sha by St. Jude Medical, Atrial Fibrillation Division, Inc.. Reason: When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and inst.
Details
Source
Device Recall
External ID
Z-0814-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Lot/Code Info: Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.
Quantity Affected: 483 units
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.
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, UT, VA, WA, and WV. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-18
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical, Atrial Fibrillation Division, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical, Atrial Fibrillation Division, Inc. have FDA actions?
This is the only FDA action we have on record for St. Jude Medical, Atrial Fibrillation Division, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0814-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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