Medtronic Cardiac Rhythm Disease Management
Country not established
- Devices
- 8
- FDA recalls
- 37
At a glance
Market reach
- United States
- FDA recalls
What Medtronic Cardiac Rhythm Disease Management makes
This manufacturer produces a range of cardiac rhythm management devices, including programmable pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). Their portfolio also includes various leads such as the CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead, along with specific models like the GEM MODEL 7227 ICD and the VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR.
These devices are classified as Class III medical devices and are listed in the FDA's Premarket Approval (PMA) database. The company is based in the United States.
Catalogue
Byrel Programable Pacemaker Ref P780009
Regimes: PMA Registry: PMA- Regimes: PMA Registry: PMA
Concerto Ii Crt-D & Various Families Of Maximo Ii & Protecta Crt-Ds' Various Families Of Consulta Icds Ref P010031
Regimes: PMA Registry: PMACapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead Ref P850089
Regimes: PMA Registry: PMAGem Model 7227 Icd Ref P900061
Regimes: PMA Registry: PMASelect Secure Lead Ref P030036
Regimes: PMA Registry: PMA- Regimes: PMA Registry: PMA
- Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 37 recalls initiated by Medtronic Cardiac Rhythm Disease Management, the earliest on 2011-04-04 and the most recent on 2015-09-15. By recorded status: 37 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 15 Sep 2015 Z-0022-2016 Class II Terminated Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
- 1 Sep 2015 Z-2777-2015 Class II Terminated An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
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- 23 Mar 2015 Z-1365-2015 Class II Terminated Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.
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- 17 Mar 2015 Z-1356-2015 Class II Terminated Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
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- 23 Feb 2015 Z-1276-2015 Class I Terminated Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
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2014
- 29 Apr 2014 Z-1661-2014 Class II Terminated Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
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- 30 Jan 2014 Z-0995-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 30 Jan 2014 Z-0996-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 30 Jan 2014 Z-0997-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 30 Jan 2014 Z-0998-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 29 Apr 2014 Z-1661-2014 Class II Terminated Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
Show the 25 most recent of 37 recalls
2014
- 30 Jan 2014 Z-0999-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 30 Jan 2014 Z-1000-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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- 30 Jan 2014 Z-0999-2014 Class II Terminated Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
2013
- 17 Jul 2013 Z-2104-2013 Class II Terminated Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
- 17 Jul 2013 Z-2105-2013 Class II Terminated Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
- 17 Jul 2013 Z-2106-2013 Class II Terminated Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
- 8 Jul 2013 Z-1876-2013 Class II Terminated Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not
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- 14 Jun 2013 Z-1966-2013 Class II Terminated Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
- 12 Jun 2013 Z-1564-2013 Class II Terminated Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
- 7 Jun 2013 Z-1607-2013 Class II Terminated Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
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- 13 Mar 2013 Z-1017-2013 Class II Terminated Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
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- 13 Mar 2013 Z-1019-2013 Class II Terminated Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
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- 19 Feb 2013 Z-0908-2013 Class II Terminated Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
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2012
- 19 Nov 2012 Z-0618-2013 Class II Terminated Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
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- 6 Mar 2012 Z-1248-2012 Not yet classified Terminated A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
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- 6 Mar 2012 Z-1249-2012 Not yet classified Terminated A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
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- 19 Nov 2012 Z-0618-2013 Class II Terminated Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
Frequently asked questions
How many devices does Medtronic Cardiac Rhythm Disease Management have in the registry?
The registry currently lists 8 devices for Medtronic Cardiac Rhythm Disease Management. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Cardiac Rhythm Disease Management's devices?
Among its 8 most recently registered devices, Medtronic Cardiac Rhythm Disease Management has devices listed in FDA PMA (8 devices).
What risk classes do Medtronic Cardiac Rhythm Disease Management's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Medtronic Cardiac Rhythm Disease Management's devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Cardiac Rhythm Disease Management?
FDA recall records list 37 recalls initiated by Medtronic Cardiac Rhythm Disease Management, the most recent initiated on 15 Sep 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medtronic Cardiac Rhythm Disease Management in the registry?
The most recently registered devices listed for Medtronic Cardiac Rhythm Disease Management include BYREL PROGRAMABLE PACEMAKER, VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS, CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS and CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead.