Recall Z-1462-2021
BIOTRONIK Inc · initiated March 8, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-1462-2021
- Initiated
- March 8, 2021
- Terminated
- April 25, 2023
- Product code
- LWS – Implantable Cardioverter Defibrillator (Non-Crt)
- Quantity
- 74 UNITS
- Distribution
- US: Nationwide OUS: Worldwide
- Recalling firm
- BIOTRONIK Inc, Lake Oswego, OR
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1441-2021 Class II | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1442-2021 Class II | BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1443-2021 Class II | BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1444-2021 Class II | BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1445-2021 Class II | BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1446-2021 Class II | BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1447-2021 Class II | BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1448-2021 Class II | BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1449-2021 Class II | BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1450-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1451-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1452-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1453-2021 Class II | BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1454-2021 Class II | BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1455-2021 Class II | BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1456-2021 Class II | BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1457-2021 Class II | BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1458-2021 Class II | BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1459-2021 Class II | BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1460-2021 Class II | BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1461-2021 Class II | BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1463-2021 Class II | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1464-2021 Class II | BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1465-2021 Class II | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |