Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.
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 involves a risk-of-harm medical device (potential intra-operative bleeding) where specific injury or illness counts are not reported in the source text, fitting the High severity criteria for theoretical or unreported harm risks.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts, specifically the Axillo-bifemoral configuration (Product Code: M002020955880). These medical devices are used for the replacement or repair of arteries affected with aneurysmal or occlusive disease.
The recall is issued because of potential small holes at the seam lines of the Hemashield branches. These defects may cause intra-operative bleeding at the seam lines of the branches during surgical procedures.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, the UK, Germany, and Japan. Specific serial numbers are listed in the official recall documentation. Healthcare providers and patients should contact Maquet Cardiovascular or their local FDA office for further instructions on handling these devices.
The recalled product
- Product
- Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Vascular Graft
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Maquet Cardiovascular, LLC 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 24 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular, LLC
See all →- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighVessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
- HighHeartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
- HighHeartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
- HighHeartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24
Same hazard · bleeding
See all →- HighHollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
FDA (Devices) · 2026-09-02
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20
- SevereArrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereNextStep Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereArrow Edge hemodialysis kits contain a sheath introducer that may not split
FDA (Devices) · 2026-05-20
Similar recalls
- HighVascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
FDA (Devices) · 2022-03-16
- HighHemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall
FDA (Devices) · 2021-12-29
- ModerateGetinge Recalls One Vascular Graft Due to Incorrect Packaging Label
FDA (Devices) · 2019-10-02
- SevereLeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking
FDA (Devices) · 2013-07-31
- CriticalLeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
FDA (Devices) · 2013-07-31
- SevereLeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
FDA (Devices) · 2013-07-31