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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2013-06-17Z-1754-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.1 unitclearance family
2013-06-17Z-1755-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.2 unitsclearance family
2013-06-17Z-1756-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.7 unitsclearance family
2013-06-17Z-1757-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.3 unitsclearance family
2013-06-17Z-1758-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.1 unitclearance family
2013-06-17Z-1759-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.3 unitsclearance family
2013-06-17Z-1760-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.1 unitclearance family
2013-06-17Z-1761-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.3 unitsclearance family
2013-06-17Z-1762-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.3 unitsclearance family
2013-06-17Z-1763-2013Class ITerminatedBlood blushing/leaking from the surface of the graft after implantationDistribution: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.2 untisclearance family
Showing 1–10 of 17
Regulatory clearances
  • 510(k)K103080Substantially equivalent (SESE) · 2011-01-19clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-08-11WLWarning LetterLeMaitre Vascular, Inc.—
2025-08-11WLWarning LetterLeMaitre Vascular, Inc.—
2025-04-16OAIOfficial action indicatedLeMaitre Vascular, Inc.8
2025-04-16OAIOfficial action indicatedLeMaitre Vascular, Inc.8
2023-05-16VAIVoluntary action indicatedLeMaitre Vascular, Inc.1
2023-05-16VAIVoluntary action indicatedLeMaitre Vascular, Inc.1
2023-04-13VAIVoluntary action indicatedLeMaitre Vascular, Inc.4
2023-04-13VAIVoluntary action indicatedLeMaitre Vascular, Inc.4
2022-06-15VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
2022-06-15VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
2020-08-27NAINo action indicatedLeMaitre Vascular, Inc.0
2020-08-27NAINo action indicatedLeMaitre Vascular, Inc.0
2018-02-16NAINo action indicatedLeMaitre Vascular, Inc.0
2018-02-16NAINo action indicatedLeMaitre Vascular, Inc.0
2017-08-01NAINo action indicatedLeMaitre Vascular, Inc.0
2017-08-01NAINo action indicatedLeMaitre Vascular, Inc.0
2015-01-28VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
2015-01-28VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
2013-03-04VAIVoluntary action indicatedLeMaitre Vascular, Inc.3
2013-03-04VAIVoluntary action indicatedLeMaitre Vascular, Inc.3
2013-01-25NAINo action indicatedLeMaitre Vascular, Inc.0
2013-01-25NAINo action indicatedLeMaitre Vascular, Inc.0
2010-05-11WLWarning LetterLeMaitre Vascular, Inc.—
2010-05-11WLWarning LetterLeMaitre Vascular, Inc.—
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