Recall Z-2074-2019— St Jude Medical Inc.
Class I · Terminated
Class I FDA medical device recall by St Jude Medical Inc., initiated 2019-06-20, terminated 2024-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585. Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices..
- Recalling firm
- St Jude Medical Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-06-20
- Terminated
- 2024-04-03
- Firm location
- Sylmar, CA, United States
Product description
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Reason for recall
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.