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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- sterility-failure
- infection-risk
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
Distributed nationwide across the United States.
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