Recall Z-1454-2021
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 INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Codes / lots: Serial Number 60841286 60869296 60870124 60870125 60870127 60870130 60870131 60870132 60870136 60870140 60870141 60870142 60870143 60873307 60873308 60873309 60873310 60873311 60873314 60873315 60873316 60873317 60873319 60873320 60873321 60873322 60873323 60873324 60873325 60873326 60875170 60875171 60875172 60875173 60875174 60875175 60875176 60875177 60875178 60875179 60878810 60878815 60878816 60878817 60878818 60878819 60878821 60878822 60878823 60878824 60878825 60878826 60878828 60878829 60878830 60878831 60878832 60878833 60878834 60878837 60878838 60880125 60880127 60880128 60880129 60880130 60880131 60880133 60880134 60880135 60880144 60880147 60880148 60880149 60881382 60881383 60881386 60881387 60881388 60881389 60881390 60881393 60881394 60881397 60881398 60881399 60881401 60881403 60881404 60881405 60881619 60881620 60881621 60881622 60881624 60881625 60881627 60881628 60881631 60881633 60881634 60881636 60881639 60881643 60881644 60881646 60883307 60883308 60883310 60883311 60883314 60883315 60883316 60883317 60883318 60883319 60883320 60883322 60883323 60883324 60883325 60883326 60884278 60884279 60884280 60884281 60884283 60884284 60884285 60884286 60884287…
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-1454-2021
- Initiated
- March 8, 2021
- Terminated
- April 25, 2023
- Product code
- MRM – Defibrillator, Implantable, Dual-Chamber
- Quantity
- 702 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-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-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 |