Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Summary
The FDA issued a Class I for Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0 by Argon Medical Devices, Inc. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterilit.
Details
Source
Device Recall
External ID
Z-2704-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Lot/Code Info: REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)
Quantity Affected: 950
Reason for Recall
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-01
Company
Athens, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Argon Medical Devices, Inc has 23 FDA actions in our database, including 13 recalls and 10 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Argon Medical Devices, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Argon Medical Devices, Inc have FDA actions?
Argon Medical Devices, Inc has 23 FDA actions in our database, including 13 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2704-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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