Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum 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 involves a medical device with a risk of intra-operative bleeding, which is a risk-of-harm product where injury has not yet been reported in the source text, fitting the High severity criteria.
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 defect where potential small holes may exist at the seam lines of the graft branches.
The identified hazard is intra-operative bleeding at the seam lines during surgical procedures. The product is used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, the UK, Germany, and Japan.
Healthcare providers and patients should check their inventory or medical records for the specific serial numbers listed in the official recall notice. If a patient has received one of these grafts, they should contact their healthcare provider for guidance on monitoring or further evaluation. No specific number of affected units or reported injuries is stated in the source text.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - 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
- 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
- CriticalLeMaitre Recalls AlboGraft Vascular Grafts Due to Surface Bleeding
FDA (Devices) · 2013-07-31