Z-2045-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- July 19, 2013
- Termination Date
- October 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
Product Description
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Reason for Recall
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
Distribution Pattern
US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
Code Information
Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18 / 9749412 FA-77400-20 / 9759088 FA-71500-35 / 9747604 FA-77375-16 / 9744487 FA-77425-16 / 9752788 FA-77300-16 / 9757068 FA-77375-20 / 9757065 FA-77425-20 / 9744123 FA-77325-14 / 9759141 FA-77400-14 / 9757233 FA-77425-20 / 9752438 FA-77325-16 / 9753034 FA-77400-14 / 9768698 FA-77450-18 / 9753033 FA-77325-16 / 9757024 FA-77400-16 / 9743468 FA-77475-20 / 9752787 FA-77325-18 / 9759560 FA-77400-18 / 9751579 FA-77500-20 / 9750678 FA-77350-16 / 9752785 FA-77400-20 / 9755707