Recall Z-1461-2021
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 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Codes / lots: Serial Number 61009745 61031041 61031948 61035465 61035477 61036566 61037118 61037352 61037354 61037367 61037371 61037377 61037383 61037384 61037386 61037393 61037940 61037953 61037966 61038664 61038665 61038672 61038679 61038700 61038701 61038705 61038709 61038710 61038711 61038715 61038720 61038722 61038731 61038732 61038905 61038929 61039138 61039376 61039377 61039381 61039384 61039385 61039388 61039393 61040798 61040953 61040966 61040978 61040988 61040992 61041010 61041405 61041407 61041495 61041500 61041509 61041543 61041560 61041569 61041572 61041588 61041590 61041830 61041834 61041852 61041855 61042207 61042208 61042219 61042260 61042267 61042320 61042330 61042343 61042928 61042942 61042944 61042965 61043039 61043075 61043283 61043551 61044057 61044061 61044100 61044246 61044258 61044262 61044279 61044280 61044284 61044285 61044286 61044288 61044305 61044306 61044312 61044318 61044324 61044325 61044330 61044336 61044338 61044341 61044485 61044491 61044505 61044605 61044609 61044611 61044613 61044615 61044618 61044622 61044629 61044630 61044644 61044649 61044650 61044655 61044901 61044905 61044906 61044914 61044925 61045369 61045379 61045406 61045424 61045714 61045724…
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-1461-2021
- Initiated
- March 8, 2021
- Terminated
- April 25, 2023
- Product code
- MRM – Defibrillator, Implantable, Dual-Chamber
- Quantity
- 1547 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-1462-2021 Class II | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product…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 |