The Recall Desk
HighFDA (Devices)·Z-0729-2022·Announced 2022-03-16

Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications

A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.

What this means for you

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: This is an FDA Class II medical device recall. The hazard—a vascular graft size mismatch that could lead to pseudo-aneurysm formation—presents a clear risk of serious patient harm. The source does not report any actual injuries or illnesses related to this labeling mismatch. This meets the 'High' severity threshold for risk-of-harm products where injury has not been documented.

Plain-English summary

Maquet Cardiovascular, LLC has recalled one lot of HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft (Lot 21B10) due to a critical labeling discrepancy. The outer product labeling indicates the graft is a bifurcated (two-branch) vascular graft measuring 16mm x 8mm in diameter and 40cm in length. However, the inner sterile packaging correctly identifies the graft as a straight (single-branch) vascular graft measuring 7mm in diameter and 60cm in length. This mismatch between outer and inner labels creates a serious risk.

Vascular grafts are medical devices surgically implanted to replace or repair arteries affected by aneurysmal or occlusive disease. If medical personnel rely on the outer label and prepare for a different graft size or type than what is actually in the sterile package, the wrong implant could be placed. This size or type mismatch could disrupt the connection between blood vessels (anastomosis) over time, potentially leading to the formation of a pseudo-aneurysm—a dangerous bulge in the arterial wall that can rupture and cause life-threatening bleeding.

This recall affects product distributed in Missouri. The affected lot number is 21B10.

The recalled product

Product
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Manufacturer
Maquet Cardiovascular, LLC
Category
Medical Device — Cardiovascular / Vascular Graft
Hazard
  • mis-labeling
  • pseudo-aneurysm-risk
  • device-size-mismatch

Distribution

Distributed nationwide across the United States.

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