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Medtronic Inc., Cardiac Rhythm and Heart Failure

Complete recall history across all FDA and CPSC categories — 9 total recalls

Medtronic Inc., Cardiac Rhythm and Heart Failure appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Medtronic Inc., Cardiac Rhythm and Heart Failure

Date Product Reason Class
Jul 14, 2017 MyCareLink Patient Monitors. It is intended for used with a compatible Med... Patients monitored on two (2) or more implanted Medtronic heart devices in th... Class II
Jul 14, 2017 MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... Patients monitored on two (2) or more implanted Medtronic heart devices in th... Class II
Apr 12, 2017 Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu... An unexpected transient mode switch behavior was detected by Medtronic during... Class II
Dec 9, 2016 Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... During internal testing conducted as part of next generation product developm... Class II
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset ... Class II
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset ... Class II
Jun 16, 2016 Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Cat... This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, ... Class II
May 26, 2016 Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... Recently, a new software version was automatically sent to a subset of Model ... Class II
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monito... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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