Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 35 of 125
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implan...
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device tri...
Z-1523-2021 May 12, 2021 Mounds View, MN
Coltene Whaledent Inc
Class II Ongoing
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the ti...
Reason: The incorrect dental pins were packaged and subsequently distributed.
Z-1494-2021 May 5, 2021 Cuyahoga Falls, OH
Omnia SRL
Class II Terminated
Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to ...
Reason: Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing f...
Z-1518-2021 May 5, 2021 Fidenza, N/A
BIOTRONIK Inc
Class II Terminated
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 l...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1462-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threate...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1448-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of l...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1464-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1453-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threat...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1442-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1443-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1456-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment o...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1463-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-th...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1447-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-th...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1450-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
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...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1461-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1458-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-t...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1455-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1449-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment o...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1459-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threat...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1441-2021 April 28, 2021 Lake Oswego, OR
Heartware, Inc.
Class I Ongoing
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU...
Reason: Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence ...
Z-1426-2021 April 28, 2021 Miami Lakes, FL
BIOTRONIK Inc
Class II Terminated
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 li...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1454-2021 April 28, 2021 Lake Oswego, OR
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1452-2021 April 28, 2021 Lake Oswego, OR
Heartware, Inc.
Class II Ongoing
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Hear...
Reason: IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very shor...
Z-1469-2021 April 28, 2021 Miami Lakes, FL
BIOTRONIK Inc
Class II Terminated
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of lif...
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Z-1457-2021 April 28, 2021 Lake Oswego, OR
Heartware, Inc.
Class II Ongoing
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. ...
Reason: IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connecto...
Z-1438-2021 April 28, 2021 Miami Lakes, FL