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BRIEF-Medtronic announces worldwide recall of its strataMR adjustable valves and shunts
April 6, 2017 / 8:52 PM / 6 months ago

BRIEF-Medtronic announces worldwide recall of its strataMR adjustable valves and shunts

April 6 (Reuters) - Medtronic Plc -

* Medtronic announces voluntary worldwide recall of its stratamr(tm) adjustable valves and shunts

* As of initiation of recall, 2,622 strataMR valves and shunts potentially affected by this recall had been distributed worldwide

* Medtronic initiated recall due to an increase in product complaint rate

* Affected strataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016

* Recall only applies to strataMR adjustable valves and shunts and does not apply to strata(tm) II or strata(tm) NSC products

* As of April 1, 2017, product complaint rate related to this issue was 2.75 percent of total units distributed

* U.S. Food and drug administration (FDA) and other regulatory bodies also have been notified of recall

* There has been one reported patient death, but cause of death has not been confirmed to be related to the issue Source text for Eikon: Further company coverage:

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