CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Hemashield Gold Knitted Microvel Double Velour Vascular recalled
Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, 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-1860-2020
- 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 Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - 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 Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product recalled?
Yes. Maquet Cardiovascular recalled Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product on 7 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1860-2020.
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: 1175590223 1175624927 1179649703 1183011925 1183008537 1183011066 1191609117 1191599092 1183020201 1183073432 1183039720
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.
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