Z-1462-2021Class II

BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 -

Name: Z-1462-2021 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 -
Creator: BIOTRONIK Inc
Published: 2021-03-08
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2021-03-08 / Terminated / root cause: design

FDA source

BIOTRONIK Inc began a recall of BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular... on 2021-03-08. FDA classified it as Class II and gives the reason as "There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1462-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-08
Posted: 2021-04-21
Terminated: 2023-04-25
Recalling firm: BIOTRONIK AG
Product: BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Root cause tag: design
FDA root cause: Device Design
Action: On 3/8/21, BIOTRONIK issued a "Urgent Field Safety" recall notification to all affected consignees via UPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. To determine if a specific device is affected by this corrective action you can lookup the device at the following web address: www.biotronik.com/devicelookup. 2. Devices in stock: Do not implant any potentially affected devices. Local BIOTRONIK representatives will replace affected devices in hospital inventory. 3. Continue with the standard patient follow-up schedule. -During follow-ups: Verify the status of the device and battery during in-office or Home Monitoring follow-ups. Please note that unresponsive devicesor those that are not transmitting data may be experiencing this issue and your BIOTRONIK representative should be informed if you observe any unusual device behavior. -Home Monitoring should be utilized whenever possible as it provides timely ERI warnings to reduce the risk of sudden loss of therapy. If you do not yet use Home Monitoring, please consider if this option is appropriate for you and your patients. BIOTRONIK will provide Cardio Messenger devices to monitor implants affected by this advisory. If you would like to register for Home Monitoring, please contact your local BIOTRONIK representative. 4. If there is an unexpected ERI notification for a device that is subject to this advisory, a timely replacement should be considered based on the patients underlying conditions: - For patients that are not pacemaker dependent, or patients with a primary prevention ICD, device replacement within one week after ERI notification is recommended. - For pacemaker dependent patients, replacement of the device is recommended immediately after ERI notification. 5. In consultation with our medical advisory board, BIOTRONIK does not recommend prophylactic replacement. The risk of complications for ICD exchange1-3 outweighs
Quantity in commerce: 74 UNITS
Distribution: US: Nationwide OUS: Worldwide
Product codes and lots: Serial Number 61091508 84702943 84730466 84730467 84730473 84731681 84732041 84733171 84733182 84733184 84733566 84733567 84733573 84733576 84733579 84733584 84733789 84733797 84734087 84734093 84734876 84734877 84735634 84735637 84735639 84735642 84737565 84737572 84737578 84737923 84738280 84738281 84738284 84738617 84738620 84738621 84739042 84739049 84739285 84739288 84740027 84740029 84740529 84740981 84741287 84741300 84741301 84741302 84741423 84741558 84741561 84741739 84741883 84741898 84742256 84742261 84743460 84743463 84743908 84743932 84744353 84746458 84746479 84749728 84749736 84753258 84754939 84755554 84755839 84756402 84756412 84761217 84761486 84761780

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1462-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1441-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1442-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1443-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1444-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1445-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1446-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1447-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1448-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1449-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1450-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1451-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1452-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1453-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1454-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1455-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1456-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1457-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1458-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1459-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1460-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1461-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1462-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1463-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1464-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1465-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)