Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls without reported deaths receive a Severe (4) rating. The non-sterility hazard in a transvenous pacing electrode—a device directly implanted in or near the heart—poses serious infection risk.
Plain-English summary
Argon Medical Devices, Inc. is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F (REF: 008416A, 008566A) containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The kits failed to meet release criteria for sterility, meaning the product does not meet required safety standards for a sterile medical device.
The affected product was distributed nationwide in the United States, including Puerto Rico, and to Trinidad and Tobago. A total of 950 units were distributed with the following lot numbers and expiration dates: REF 008416A (Lot 11656898, expires 7/19/2027) and REF 008566A (Lots 11654475 and 11654478, expires 7/19/2027 and 12/31/2026 respectively).
Healthcare providers and patients who have this product should stop using it and contact Argon Medical Devices, Inc. for instructions on return or replacement. Patients with questions about their medical care should consult their healthcare provider.
The recalled product
- Product
- Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 950
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 008566A/20886333217643:00886333217649/11654475(12/31/2026)
- 11654478(7/19/2027)
Distribution
Part of a larger recall action
This product is one of 6 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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