Home › VASCUTEK LTD › SealPTFE™
SealPTFE™
VASCUTEK LTD · Model S2005S · UDI-DI 05037881002736
MAL
Prescription
6
510(k) clearances
878
Adverse events (43 deaths)
49
Recalls
7
Facilities
Description
SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Maquet Cardiovascular, LLC | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (H |
| 2021-12-01 | Maquet Cardiovascular, LLC | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 | Maquet Cardiovascular, LLC | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.