CLASS II Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
Hemashield Gold Knitted Microvel Double Velour Vascular recalled
Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Graft- D:; L: Indicated for use, distributed nationwide in the US. The recall was initiated on 14 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0729-2022
- FDA event ID
- 89573
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2022
- FDA classified
- 7 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 14 Jan 2022 | Recall initiated by company | |
| 7 Mar 2022 | Classified by FDA | +52 days |
| 16 Mar 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the state of MO.
Questions about this recall
Is Hemashield Gold Knitted Microvel Double Velour Vascular Graft- D:; L: Indicated for use recalled?
Yes. Maquet Cardiovascular recalled Hemashield Gold Knitted Microvel Double Velour Vascular Graft- D:; L: Indicated for use on 14 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0729-2022.
Why was it recalled?
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Which lots are affected?
Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
Where was it sold?
US Nationwide distribution in the state of MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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