Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that could 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 is classified as FDA Class II, and the hazard involves a risk of harm (intra-operative bleeding) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch. The recall is due to a potential defect where small holes may exist at the seam lines of the graft branches. This defect poses a risk of intra-operative bleeding during surgical procedures.
The affected product is used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The recall covers units distributed worldwide, including the United States and various international markets such as Canada, the UK, Germany, and Japan. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare providers and patients should check their records for the presence of these specific serial numbers. If a patient has received a graft with one of the listed serial numbers, they should contact their healthcare provider for further evaluation and guidance. No specific instructions for consumer disposal are provided in the source text, as this is a medical device used in surgical settings.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - 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
- Hazard
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
- HighHemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall
FDA (Devices) · 2021-12-29
- HighVascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
FDA (Devices) · 2022-03-16
- ModerateGetinge Recalls One Vascular Graft Due to Incorrect Packaging Label
FDA (Devices) · 2019-10-02
- HighFusion Bioline Vascular Graft recalled due to manufacturing straightness defect
FDA (Devices) · 2023-03-22
- CriticalLeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage
FDA (Devices) · 2013-07-31
- SevereLeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
FDA (Devices) · 2013-07-31