Critical Alert
Argon Medical Devices Recalls Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2704-2026Medical Device
Argon Medical Devices Recalls Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing
Argon Medical Devices, Inc · Class I — Most Serious
Product Description
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
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.
FDA Classification
Class I — Most Serious
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.
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. Argon Medical Devices, Inc initiated this recall of medical device on June 1, 2026 affecting 950. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. The product was distributed nationwide. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.