(Jan. 7, 2021) Stryker Neurovascular has recalled a stroke device that could cause serious injuries or death. Stryker reported that it has received reports of one death and 11 injuries related to the device. As a result, the FDA issued a Class I recall in November 2020, the agency’s most serious type of recall.
Trevo XP ProVue Retriever Core Wire May Break or Separate
Stryker said that its Trevo XP ProVue Retriever is designed to restore blood flow or remove blood clots in a blood vessel in the brain during an acute ischemic stroke. According to Stryker, the core wire could break or separate, causing the device to lodge inside a patient’s blood vessels or tissues. That could lead to bleeding, disability, or death.
Stryker said that it has notified all of its customers, requesting that they return the devices.
FDA Notice of the Recalled Device:
- Trevo XP ProVue Retriever
- Catalog Numbers and Lot Numbers: Full List of Affected Devices
- Manufacturing Dates: July 22, 2019 to September 9, 2019
- Distribution Dates: September 18, 2019 to July 7, 2020
- Devices Recalled in the U.S.: 1,258
- Date Initiated by Firm: September 21, 2020
The Problem with the TrevoXP ProVue Retriever
Stryker Neurovascular is recalling the Trevo XP ProVue Retriever device because there is a risk the core wire may break or separate when the core wire is retracted during use. If this occurs, the device could be left inside the patient’s blood vessel or tissue. The use of affected devices may cause serious adverse health consequences, including bleeding, additional blockage of blood vessels, disability, and death.
Those Who May be Affected
- Health care providers using the Trevo XP ProVue Retriever
- Patients undergoing procedures involving the Trevo XP ProVue Retriever
What should those concerned do?
Stryker Neurovascular sent a notice on Sept. 21, 2020 to all its affected customers, providing these instructions:
- Immediately check your internal inventory for affected devices.
- Segregate the affected units in a secure location for return to Stryker.
- Circulate this Recall-Removal notice internally to all interested and affected parties.
- Maintain awareness of this communication internally until all required actions have been completed within your facility.
- Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.
- Inform Stryker of any adverse events concerning the use of the recalled devices.
- Complete Stryker’s customer response form and email it to NVCustomerCare@Stryker.com. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter.
- Product return information will be provided to you by your designated Stryker territory manager or sales representative.
Customers with questions may contact Stryker Customer Care by email at NVCustomerCare@Stryker.com or by phone at 1-855-916-3876.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.