St. Jude Medical, Cardian Rhythm Management Division
St. Jude Medical, Cardian Rhythm Management Division appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1530-2021, Class I) was initiated on March 15, 2021.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1530-2021 | Class I | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacema | March 15, 2021 |
| Z-1531-2021 | Class I | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and | March 15, 2021 |