The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Penumbra 3D Revascularization Device
- Lot Numbers: C00644, C00645, C00646, C00717
- Distribution Dates: May 15, 2017 to June 7, 2017
- Manufacturing Dates: March 31, 2017 to April 28, 2017
- Devices Recalled in the U.S.: 155 nationwide
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.
Reason for Recall
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.
Who May be Affected
- Health care providers using this device during revascularization procedures
- All patient groups undergoing procedures involving the Penumbra 3D Revascularization device
What to Do
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@penumbrainc.com.
Penumbra Inc. will contact customers directly to arrange return of affected units and replacement of returned product, free of charge.
Health care professionals and customers may contact their Penumbra sales representative or Penumbra Customer Service at 1-888-272-4606, between the hours of 8:00 a.m. and 5:00 p.m. Pacific Standard Time or by email at RAQA@penumbrainc.com with any questions related to this recall.
Date Recall Initiated
June 8, 2017
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 either online, by regular mail or by FAX to 1-800-FDA-0178.