Stryker Neurovascular Recalls Trevo XP ProVue Due to Risks of Injury and Death Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Faulty Core Wire that Could Break or Separate During Retraction; Risks of Injury and Death UNITED STATES – According to news report published on bioworld.com and fda.gov the FDA has recognized Stryker Neurovascular’s […]
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Faulty Core Wire that Could Break or Separate During Retraction; Risks of Injury and Death
Trevo xp ProVue Retriever recall
UNITED STATES – According to news report published on bioworld.com and fda.gov the FDA has recognized Stryker Neurovascular’s (Stryker) recall of its Trevo XP ProVue Retriever device as a Class I recall, which is the most serious type of recall in the United States. The faulty device has been recalled due to the fact that it may cause severe injuries and death after the breakage or separation of the product.
The intended use of the Trevo XP ProVue Retriever is to restore the flow of blood or remove blood clots within a certain blood vessel in the brain that form during an acute ischemic stroke.
The devices that are subject to the recall are:
The FDA Class I recall involves the following products:
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM).
Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002.
For further information on the recall, visit accessdata.fda.gov.
The dates of manufacture of the device are from July 22, 2019 to September 9, 2019. The distribution dates are from September 18, 2019 to July 7, 2020. The number of devices recalled in the United States is 1,258.
Stryker has issued its recall due to the risk that the core wire may separate or break when it is being retracted during its use. If this happens, parts of the core wire may be left in a person’s body (within a blood vessel or tissue). There are adverse health risks associated with the use of the device, including additional blockage of blood vessels, disability, bleeding, and death. Altogether, there have been eleven reports of illness or injury due to the use of the device and one fatality.
Customers with questions may contact Stryker Customer Care by visiting their website.
Parker Waichman LLP is reviewing cases of personal injury and wrongful death claims stemming from the recently recalled Stryker Neurovascular Trevo XP ProVue. Parker Waichman LLP helps those harmed by defective products secure monetary compensation from those responsible. Trust your case with our product liability attorneys. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
