Recall archive
28 recalls · page 2 of 2
Reported Nov 14, 2018
Medtronic CareLink 2090 Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Single Chamber Temporary External Pacemaker, Model 53401
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use…
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy…
7 more products in this recall
FDA (openFDA device enforcement)
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