Medtronic Guide Catheter Recalled for Potential Sterility Compromise
Medtronic Vascular is recalling 10 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection from compromised sterility in a medical device.
Plain-English summary
Medtronic Vascular is recalling 10 units of the 6F Launcher Guide Catheter 100cm EBU 3.75 (Model Number: LA6EBU375). The recall is due to a potential compromise in sterility caused by unsealed pouches.
The affected products are identified by Lot Codes 220772561 and 220772562. The recall is classified as Class II by the U.S. Food and Drug Administration. The distribution pattern for these units is nationwide.
Healthcare providers and facilities should check their inventory for the specific model and lot codes listed. 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 100cm EBU 3.75 Model Number: LA6EBU375
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Catheter
- Affected units
- 10
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)
- Lot Code: 220772561
- 220772562
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
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