Z-2071-2019Class I

ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

Name: Z-2071-2019 ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Creator: St Jude Medical Inc.
Published: 2019-06-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-06-20 / Terminated / root cause: manufacturing process

FDA source

St Jude Medical Inc. began a recall of ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) on 2019-06-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2071-2019
Classification: Class I
Status: Terminated
Initiated: 2019-06-20
Posted: 2019-08-02
Terminated: 2024-04-03
Recalling firm: Abbott Medical
Product: ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 47
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
Product codes and lots: Serial Number: 1281828, 1281840, 1282688, 1282724, 1282734, 1283113, 1283627, 1283633, 1283634, 1283639, 1283641, 1283643, 1283646, 1283648, 1283656, 1283657, 1283659, 1283660, 1283672, 1283680, 1283681, 1283683, 1283689, 1283690, 1283692, 1283695, 1283697, 1283703, 1283704, 1283708, 1283742, 1283747, 1283749, 1283766, 1283772, 1283780, 1283783, 1283784, 1283788, 1283832, 1283838, 1283845, 1283868, 1283884, 9831441, 9831445, 9831759

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2070-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2071-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2072-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2073-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2074-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2075-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)