ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

FDA device recall Z-2074-2019 · posted 2019-08-02 · Terminated

Recall details

Recalling firm

St Jude Medical Inc.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LWS

Quantity affected

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

Date initiated

2019-06-20

Date posted

2019-08-02

Date terminated

2024-04-03

Location

Sylmar, CA