DSWClass IImplant
Bag, Polymeric Mesh, Pacemaker
Cardiovascular · 21 CFR 870.3650
MDR events8All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances0All time
Recent MDR events
8 adverse event reports on file
- ULTIMA ACTIVATOR II REUSABLE DRIVE MECHNov 26, 2024MalfunctionMaquet Cardiovascular Llc2242352-2024-0001319
- ULTIMA ACTIVATOR II REUSABLE DRIVE MECHOct 11, 2021MalfunctionMaquet Cardiovascular Llc2242352-2021-00827
- ULTIMA ACTIVATOR II REUSABLE DRIVE MECHOct 11, 2021MalfunctionMaquet Cardiovascular Llc2242352-2021-00829
- CENTRIMAG MOTOR, OUSAug 11, 2018MalfunctionThoratec Switzerland Gmbh2916596-2018-03422
- CENTRIMAG MOTOR, OUSAug 11, 2018MalfunctionThoratec Switzerland Gmbh2916596-2018-03413
- CENTRIMAG MOTOR, OUSAug 11, 2018MalfunctionThoratec Switzerland Gmbh2916596-2018-03403
- CENTRIMAG MOTOR, OUSAug 11, 2018MalfunctionThoratec Switzerland Gmbh2916596-2018-03423
- CENTRIMAG MOTOR, USAug 9, 2018MalfunctionThoratec Switzerland Gmbh2916596-2018-03419
Event type breakdown
Malfunction8
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Mechanical Problem5
Corroded3
Trend for “Mechanical Problem”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.