Medtronic Inc. Cardiac Rhythm Disease Management
Complete recall history across all FDA and CPSC categories — 23 total recalls
Medtronic Inc. Cardiac Rhythm Disease Management 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 (23)
FDA medical device enforcement actions by Medtronic Inc. Cardiac Rhythm Disease Management
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 15, 2015 | Medtronic Medical Device Identification Card for SureScan pacemaker patients.... | Some Medical Device Identification Cards provided to SureScan pacemaker patie... | Class II |
| Sep 1, 2015 | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... | An issue with a USB memory component contained within a subset of CryoConsole... | Class II |
| Mar 23, 2015 | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 a... | Class II |
| Mar 17, 2015 | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... | Possible performance issue when used with specific AA-sized (LR6) batteries. ... | Class II |
| Feb 23, 2015 | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath... | Clinicians observed debris, appearing to originate from the hemostasis valve ... | Class I |
| Apr 29, 2014 | Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... | Events related to a pacing rate outside of the intended setting, including ev... | Class II |
| Jan 30, 2014 | Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jan 30, 2014 | Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jan 30, 2014 | Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jan 30, 2014 | Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jan 30, 2014 | Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jan 30, 2014 | Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Ca... | Class II |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... | Medtronic was notified that Edwards Lifesciences has initiated a product reca... | Class II |
| Jul 17, 2013 | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... | Medtronic was notified that Edwards Lifesciences has initiated a product reca... | Class II |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... | Medtronic was notified that Edwards Lifesciences has initiated a product reca... | Class II |
| Jul 8, 2013 | Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... | Medtronic identified a specific labeling issue for specific lots of Mullins T... | Class II |
| Jun 14, 2013 | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufac... | Class II |
| Jun 12, 2013 | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... | Medtronic has identified a labeling issue for 24 units of the Launcher corona... | Class II |
| Jun 7, 2013 | Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and... | Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and S... | Class II |
| Mar 13, 2013 | Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W... | Medtronic has identified an issue involving specific lot numbers of the Medtr... | Class II |
| Mar 13, 2013 | Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ... | Medtronic has identified an issue with a specific lot of the Archer 0.035 inc... | Class II |
| Feb 19, 2013 | Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul... | Potential for uncharacteristically rough metal edges to occur along the inner... | Class II |
| Nov 19, 2012 | Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... | Medtronic is initiating an Urgent Medical Device Customer Notification. We h... | 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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