FDA Medical Device Recalls (openFDA)
St Jude Medical Inc.: ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
- Recall number
- Z-2074-2019
- Recalling firm
- St Jude Medical Inc.
- Product
- ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
- Status
- Terminated
- Initiated
- 2019-06-20
- Posted
- 2019-08-02
- Terminated
- 2024-04-03
- 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.
- Root cause
- Process control
- Action
- On 06/20/19, Sales Representatives visited impacted customer accounts to provide talking points that included the reason for recall and to retrieve affected devices. On 06/21/19, hand-delivery of Urgent Medical Device Recall Notices, to physicians supporting implanted patients, commenced. Customers were informed that there is no available option to verify the vulnerability status for implanted devices. Device explant and replacement are recommended. Customers were advised to: 1) Review the device model and serial numbers in the appendix of this letter to identify the impacted patients and return the acknowledgement form to your sales representative; and 2) Device explant and replacement are recommended. The recalling firm will work with customers to provide a replacement device. A copy of this letter is available on https://www.cardiovascular.abbott/us/en/hcp/resources/product/advisories.html. Customers with additional questions were encouraged to call 1-800-727-7846 (Opt3), 8:30am - 5:30pm Central Time, Monday thru Friday.
- Quantity
- 15
- Distribution
- 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
- Lot, serial or model codes
- Serial Number: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546
- 510(k) numbers
- not on file
- PMA numbers
- ["P910023S309"]
- Product code
- LWS
- Firm FEI
- 2017865
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28