Z-1512-2020Class II

Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 -

Name: Z-1512-2020 Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 -
Creator: Boston Scientific Corporation
Published: 2020-02-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-02-12 / Terminated / root cause: software

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are... on 2020-02-12. FDA classified it as Class II and gives the reason as "Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1512-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-12
Posted: 2020-03-03
Terminated: 2023-04-14
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.
Quantity in commerce: 1 device
Distribution: US Nationwide distribution in the states of NC, TN, and MO.
Product codes and lots: Serial Number 516959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1511-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18
Z-1512-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18

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)