FDA (Devices) recall action 94674
The FDA (Devices) publishes a recall like this one as 23 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 23 pages.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.
Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.
Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.
Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.
Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.
Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.
Medtronic is recalling EVERA S VR implantable cardioverter defibrillators due to a potential manufacturing defect involving a weld crack that can cause device failure. The defect was identified during manufacturing leak testing.
Medtronic is recalling two PRIMO MRI DR SureScan implantable cardioverter defibrillators due to a potential manufacturing defect involving weld cracks detected during manufacturing quality testing.
Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.
Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.
Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.
Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.
Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.
Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.
Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.
Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.
Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.
Medtronic is recalling 6 units of the MIRRO MRI VR SureScan implantable cardioverter defibrillator due to a potential manufacturing defect. The devices failed manufacturing quality checks because of a weld crack.
Medtronic is recalling 82 implantable cardioverter defibrillators due to a manufacturing defect involving weld cracks discovered during quality control testing before distribution to patients.
Medtronic is recalling 58 COBALT XT HF QUAD implantable cardioverter defibrillators worldwide due to a weld crack manufacturing defect that caused devices to fail quality checks.
Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.
Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.
Medtronic is recalling five units of its EVERA MRI S DR SureScan implantable cardioverter defibrillator due to a manufacturing defect—a weld crack that caused failure during quality control testing.