Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise
Medtronic Vascular is recalling 137 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
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 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 recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where sterility compromise poses a significant risk of infection.
Plain-English summary
Medtronic Vascular is recalling 137 units of the 6F Launcher Guide Catheter 100 cm EBU 3.0 (Model Number: LA6EBU30). The recall is due to a potential sterility compromise caused by unsealed pouches.
The affected product is identified by Lot Code 220857555 and was distributed nationwide. The FDA has classified this recall as Class II.
Healthcare providers and facilities should check their inventory for the specific model and lot number listed above. If the product is found, it should be removed from use and returned to Medtronic Vascular according to their instructions.
The recalled product
- Product
- Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Catheter
- Affected units
- 137
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 Code: 220857555
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Medtronic Vascular 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Medtronic Vascular
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- HighMedtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
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- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
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Similar recalls
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