FDA MedWatch - Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use

AUDIENCE: Cardiology, Risk Manager

ISSUE: Penumbra Inc. is recalling the Penumbra 3D Revascularization device because there is a risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.

BACKGROUND: As part of the Penumbra System, the Penumbra 3D Revascularization device is intended to restore blood flow or remove thrombus (blood clot) within a blood vessel in the brain during an acute ischemic stroke in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy.

RECOMMENDATION: On June 9, 2017, Penumbra Inc. sent an Urgent Voluntary Removal notice to all affected customers. The notice asked customers to:

• Identify and remove any affected 3D Revascularization devices from inventory and quarantine.
• Complete and return the Penumbra Product Identification/Return Notification by fax at 1-510-217-6414 or email at RAQA@xxxxxxxxxxxxxxx.

Penumbra Inc. will contact customers directly to arrange return of affected units and replacement of returned product, free of charge.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm567990.htm

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