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- 4 Branch, 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-1881-2020
- 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- 4 Branch, Product Code: M00202175928P0 - 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
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: 1136650764 1136649656 1138918524 1139377657 1143579436 1143599946 1147678079 1152754107 1158302730 1159727382 1159721538 1163859207 1166883762 1172730370 1177896586 1138937162 1141871928 1148785668 1152764001 1158785925 1159740547 1163841540 1168007426 1177892046
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 85420This product is part of a recall event; the main page for the event is Hemashield Platinum Woven Double Velour Vascular Graft recalled.
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