Hemashield Double Velour Cardiovascular Fabrics recallZ-2062-2010 · 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-2062-2010
- 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
- DXZ
- FDA submissions
- K955349
- Distribution
- Nationwide Distribution.
Product description
Hemashield Double Velour Cardiovascular Fabrics.
Code information (models, lots, serial numbers)
xxx
Other devices under the same FDA submission
5 devices cleared under K955349 — 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 M002000195140Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall2 reports
- Hemashield M002000196240Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene10 reports
- Hemashield M002000196270Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 reports
- Hemashield M002000195290Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
- Hemashield M002000195090Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56004).
- Z-2063-2010 · TerminatedHemashield Platinum Woven and Knitted Double Velour Vascular Grafts.
- 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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