CardioCommand Transesophageal Cardiac Pacing System Recalled for Battery Corrosion
Cardiocommand Inc. is recalling five units of its Transesophageal Cardiac Pacing and Recording System, Model 7A, due to possible corrosion of the battery contacts.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a potential mechanical defect (corrosion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardiocommand Inc. is recalling five units of the Transesophageal Cardiac Pacing and Recording System, Model 7A (REF 0101). The recall is due to possible corrosion of the battery contact(s). The affected units have serial numbers 8059, 8060, 8022, 8063, and 8211.
The device is used for temporary left atrial pacing to treat bradycardia, hypotension, or AV junctional rhythm, as well as for antitachycardia pacing and esophageal electrocardiography. The units were distributed nationwide in the states of Connecticut, Vermont, Ohio, Illinois, and Delaware.
The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- Product
- CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or
- Manufacturer
- Cardiocommand Inc.
- Category
- Medical Device — Cardiac Pacing
- Affected units
- 5
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 (5)
- Serial Numbers: 8059
- 8060
- 8022
- 8063
- 8211
Distribution
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