Medtronic Abre Venous Self-expanding Sent System Recall for Incorrect Size Labeling
Medtronic is recalling 23 Abre Venous Self-expanding Sent Systems because the device size is incorrectly printed on the device itself, though the packaging is labeled correctly.
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 involves a labeling error (incorrect size printed on the device) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Inc. is recalling 23 units of the Abre Venous Self-expanding Sent System, catalog number REF AB9U16080090. The recall is due to an incorrect size printed on the device, while the packaging is labeled correctly. The devices are intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
The affected devices are identified by UDI 00643169796348 and Lot Number B086915. These units were distributed nationwide in the United States, specifically in the states of North Carolina, Colorado, California, Arizona, Montana, and Missouri.
Healthcare providers and patients should contact Medtronic for further instructions regarding the return or replacement of these devices. This recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 23
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)
- UDI 00643169796348
- Lot Number B086915
Distribution
Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighMedtronic Abre Venous Stent System recalled for reports of stent migration
FDA (Devices) · 2022-01-12
- HighMedtronic Abre Venous Stent System Recalled for Sterile Package Breach
FDA (Devices) · 2024-03-27
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateMedtronic Recalls Everflex Self-Expanding Peripheral Stents Due to Labeling Error
FDA (Devices) · 2017-12-06
- ModerateMedtronic Hancock II Mitral Bioprosthesis Recalled for Incorrect Size Labeling
FDA (Devices) · 2019-07-03
- ModerateMedtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling
FDA (Devices) · 2019-07-03