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October 30, 2020 04:00am
By Jennifer Gershman, PharmD, CPh
Implantation of the product could cause underdrainage of cerebrospinal fluid.
Medtronic plc has announced a voluntary worldwide recall of all unused units of its StrataMR adjustable valves and shunts.
As of the initiation of the recall, 2622 StrataMR valves and shunts potentially affected by the recall have been distributed worldwide, according to the FDA.
The affected valves and shunts were manufactured from October 27, 2015, to November 11, 2016. The recall was initiated after an increase in product complaints. To date, complaints related to the StrataMR valves and shunts have accounted for 2.75% of total units distributed.
StrataMR adjustable valves and shunts are used in the management of hydrocephalus, and they control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure, according to the FDA.
Medtronic notified customers of the recall on February 22, 2017, because of an issue that can occur post-implantation that can lead to underdrainage of cerebrospinal fluid. Associated adverse effects can include headaches, nausea, vomiting, and lethargy. If left untreated, underdrainage could result in coma and death.
So far, 1 patient death has been reported, but the cause of death has not been confirmed to be related to the issue.
If any of the affected products have been implanted in patients, physicians should refer to the customer recall letter sent in February, in addition to the valve adjustment instructions for use for continued patient care, according to the FDA.
In addition, patients and their caregivers should monitor patient condition. If they are experiencing any of the adverse events previously listed, they should consult the physician who implanted the StrataMR valve.
“Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected products that remain in inventory and return all unused units to Medtronic.
The recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products.