Reported Aug 12, 2015 · Terminated
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve…
Medtronic Cardiovascular Surgery-the Heart Valve Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Cardiovascular Surgery-the Heart Valve Division · 1851 E Deere Ave · Santa Ana, CA · 92705-5720
Is this the product you have?
- EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
- Lot codes and dates
74 of 74 codes
000725481400072664130007332504000733250600073325080007332510000734332100073433240007343327000735082500073508370007354113000735424500073669490007369883000739309800073931010007408862000740886500074088670007408869000742825800074282600007428263000743516900074393580007439360000743936200074562920007456298000746290100074629030007462905000747621500074762170007476219000748221900074822220007482226000748682600074923560007495691000749569400074956960007508883000750888500075088910007515698000751570000075157030007522595000752259800075226000007522603000753096300075309730007537892000753789400075694740007569477
- Amount recalled
- 6,912 units total (540 units in US)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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