Hemashield Platinum Woven and Knitted Double Velour… recallZ-2063-2010 · Maquet Cardiovascular, LLC · initiated May 24, 2010
Terminated All recalls posted in July 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
FDA root cause category: Package design/selection
What the company is doing
Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.
Recall details
- Recall number
- Z-2063-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 24, 2010
- Posted by the FDA
- Jul 22, 2010
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- xx
- Product code
- MAL
- FDA submissions
- K021213
- Distribution
- Nationwide Distribution.
Product description
Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.
Code information (models, lots, serial numbers)
xxx
Other devices under the same FDA submission
29 devices cleared under K021213 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemashield M00202166168P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall3 reports
- Hemashield M00202175928P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite10 reports
- Hemashield M00202175208P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175210P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175430P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite6 reports
- Hemashield M00202175132P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M00202175410P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M00202175926P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite5 reports
- Hemashield M00202175428P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175826P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175830P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
- Hemashield M00202175924P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 56004).
- Z-2062-2010 · TerminatedHemashield Double Velour Cardiovascular Fabrics.
- Z-2064-2010 · TerminatedHemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
- Z-2066-2010 · TerminatedHemashield Gold Woven and Knitted Double Vascular Grafts.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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