Medtronic Recalls Thoracic Stent Grafts Due to Flushing Difficulty
Medtronic Vascular is recalling Valiant and Talent Thoracic Stent Grafts with Captivia Delivery Systems because the graft cover is difficult to flush during preparation.
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, and the source text describes a procedural difficulty during device preparation without reporting any patient injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Medtronic Vascular, Inc. is recalling approximately 1,000 units of Valiant Thoracic Stent Grafts and Talent Thoracic Stent Grafts equipped with the Captivia Delivery System. The recall was initiated after the firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation, a step required by the Instructions for Use (IFU).
The affected devices were distributed internationally to Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. The recall is classified as Class II by the FDA.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Vascular for instructions on how to return or dispose of the product. Patients who have already had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,000
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 (9)
- TBXXXXXXXXCP
- TFXXXXXXXXCP
- TWXXXXXXXXCP
- TAXFXXXXXXXCP
- TAXWXXXXXXXCP
- VAMFXXXXXXXXTE
- VAMCXXXXXXXXTE
- VAMFXXXXXXXXTU
- VAMCXXXXXXXXTU.
Distribution
Distribution scope not specified by the agency.
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