CLASS I Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Ellipse DR recalled by St Jude Medical

St Jude Medical is recalling Ellipse DR, distributed nationwide in the US. The recall was initiated on 20 Jun 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516

Quantity recalled21

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2073-2019
FDA event ID: 83252
Recalling firm: St Jude Medical, Sylmar, CA
Classification: Class I
Status: Terminated
Recall initiated: 20 Jun 2019
FDA classified: 2 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

20 Jun 2019	Recall initiated by company
2 Aug 2019	Classified by FDA	+43 days
14 Aug 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

Where it was distributed

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

Nationwide Delaware Illinois

Questions about this recall

Is Ellipse DR recalled?

Yes. St Jude Medical recalled Ellipse DR on 20 Jun 2019. The recall is Class I and its status is Terminated. Recall number Z-2073-2019.

Why was it recalled?

Which lots are affected?

Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from St Jude Medical

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Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Merlin.net Patient Care Network recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	13 states
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN

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