Medtronic Launcher Coronary Guide Catheter Recalled for Incorrect Length
Medtronic Vascular is recalling 11 Launcher Coronary Guide Catheters because they have a usable length of 90 cm instead of the labeled 55 cm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, which typically corresponds to a moderate severity where the product could cause temporary or medically reversible health consequences, but no serious injury or death is reported in the source text.
Plain-English summary
Medtronic Vascular is recalling 11 units of the Medtronic Launcher Coronary Guide Catheter, Model LA6JR40K, Lot Number 0007244836. The recall was initiated after two reports indicated that the catheters had a usable length of 90 cm, whereas the packaging label specified a usable length of 55 cm.
The affected devices were distributed in the United States, including the states of North Carolina, Iowa, Illinois, and Kansas. The discrepancy in length is a labeling and product specification error where the physical device did not match the information provided on the packaging.
Healthcare providers and patients should stop using the affected catheters and contact Medtronic Vascular for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
- Affected units
- 11
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 (1)
- Lot Number: 0007244836 MODEL: LA6JR40K
Distribution
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