Medtronic Heart Valve Division
Spring Lake Park, MN
Medtronic Heart Valve Division appears in FDA device records in Spring Lake Park, MN. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1775-2008 | Hall Easy-Fit Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken. | Medtronic has identified an issue with 685 Hall Easy-Fit valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve. | Terminated | ||
| Z-1774-2008 | Hall Easy-Fit Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken. | Medtronic has identified an issue with 685 Hall Easy-Fit valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain