Medtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
Medtronic Vascular is recalling 6F Launcher Guide Catheters because an unsealed pouch 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic Vascular is recalling the 6F Launcher Guide Catheter 100 cmJL 3.5 (Model Number: LA6JL35). The recall is due to a potential sterility compromise caused by an unsealed pouch.
The affected product is identified by Lot Code 220712186. The recall is classified as Class II by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide.
Healthcare providers and facilities should check their inventory for this specific lot code and discontinue use of the affected units. Patients who have received this device should contact their healthcare provider for guidance.
The recalled product
- Product
- Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1
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: 220712186
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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- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
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- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Rashkind Balloon Septostomy Catheter Recall for Quality Failures
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