Medtronic Recalls

What's with all the recalls lately?

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probably because most full time employees and managers don’t even work 20 hours a weeks, from what I saw, while treating the contractors like doormats and an easy excuse to save money after recalling about 160, 000 and hiding this from once

Were they the ones working on StealthStation?

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probably because most full time employees and managers don’t even work 20 hours a weeks, from what I saw, while treating the contractors like doormats and an easy excuse to save money after recalling about 160, 000 and hiding this from once

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The FDA today labeled a select recall of Medtronic HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I.

First the VAD's and now 157,000 dual chamber pacers recalled. Clear the building because CVG is going up in flames.

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The FDA today labeled a select recall of Medtronic HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I.

FDA labels Medtronic HVAD splice kit recall as Class 1

The FDA today labeled a select recall of Medtronic (NYSE:MDT) HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could […]

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HeartWare has had controller and battery problems for years. Seems they never really addressed their Warning Letter. The government won't be fooled twice, will they

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

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and now the HVAD recall is labeled a Class I.

HeartWare has had controller and battery problems for years. Seems they never really addressed their Warning Letter. The government won't be fooled twice, will they

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Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR(TM) adjustable valves and shunts. These products are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the company's Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata(TM) II or Strata(TM) NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.

Another Class I recall.

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Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR(TM) adjustable valves and shunts. These products are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the company's Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata(TM) II or Strata(TM) NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.

A number have valves have been explanted for lack of flow and post explant tests are confirming the returned valves do not meet pressure flow requirements. Either the Strata manufacturing has changed or there are new faults in the process.

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Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR(TM) adjustable valves and shunts. These products are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the company's Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata(TM) II or Strata(TM) NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.

Medtronic Announces Voluntary Worldwide Recall of its StrataMR(TM) Adjustable Valves and Shunts

Medtronic Announces Voluntary Worldwide Recall of its StrataMR(TM) Adjustable Valves and Shunts

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DUBLIN - April 5, 2017 - Medtronic (NYSE: MDT) is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. The reported incidence of this condition is approximately one (1) reset in every seven million hours of ventilation. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator.

A Newport HT70 ventilator is used to support a patient's breathing. This prescription device is operated by trained healthcare professionals in a clinical setting and in the home for infant, pediatric and adult patients.

Medtronic Announces Worldwide Voluntary Field Corrective Action For Newport(TM) HT70 and Newport(TM) HT70 Plus Ventilators

Medtronic Announces Worldwide Voluntary Field Corrective Action For Newport(TM) HT70 and Newport(TM) HT70 Plus Ventilators

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SynchroMed has been recalled by itself more times than most companies have any products recalled. Hire Apple or Facebook if you can't figure out how to program the software so it doesn't kill people.

And these issues just screwed RemoSynch getting approved anytime soon.

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SynchroMed has been recalled by itself more times than most companies have any products recalled. Hire Apple or Facebook if you can't figure out how to program the software so it doesn't kill people.

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