Agency classClass IIOur severity:High FDA (Devices)·Z-1878-2020·Announced 2020-05-13

Maquet Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes

Maquet 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.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific units of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch. The recall is issued because of potential small holes at the seam lines of the graft branches, which could cause intra-operative bleeding during surgery.

The affected product is used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The recall includes units with serial numbers 1133295245 and 1143826089. These products were distributed worldwide, including in the United States and various international locations such as Canada, the UK, Germany, and Japan.

Healthcare providers and facilities should check their inventory for the specific serial numbers listed and stop using these devices. The source text does not specify a direct action for individual consumers, as this is a medical device used in clinical settings.

The recalled product

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - 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: bleeding
manufacturing-defect

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 (1)

Serial Numbers: 1133295245 1143826089

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 →

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Same hazard · bleeding