Z-2070-2019 Class I Terminated
FDA device recall Z-2070-2019 was initiated by St Jude Medical Inc. on June 20, 2019 and is designated Class I. 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 potenti… The recall status is terminated (terminated April 3, 2024). Affected quantity: 27.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- June 20, 2019
- Termination Date
- April 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27
Product Description
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
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.
Distribution Pattern
Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO
Code Information
Serial Number: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606