CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Hemashield Platinum Woven Double Velour Vascular Graft recalled
Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Graft-3 Branch, Product, distributed nationwide in the US. The recall was initiated on 7 Apr 2020 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-1877-2020
- FDA event ID
- 85420
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2020
- FDA classified
- 4 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 7 Apr 2020 | Recall initiated by company | |
| 4 May 2020 | Classified by FDA | +27 days |
| 13 May 2020 | 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
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Product as listed by the FDA
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
Questions about this recall
Is Hemashield Platinum Woven Double Velour Vascular Graft-3 Branch, Product recalled?
Yes. Maquet Cardiovascular recalled Hemashield Platinum Woven Double Velour Vascular Graft-3 Branch, Product on 7 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1877-2020.
Why was it recalled?
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Which lots are affected?
Serial Numbers: 1161660408 1161660759 1161660154 1168595437 1168596216 1168588836 1168591619 1168601507 1168586068 1174957059 1174946035
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
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.
More recalls from Maquet Cardiovascular
All 252| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Sterility | Nationwide |
| Device | CLASS II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Device Malfunction | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |