FDA Medical Device Recalls (openFDA)
Micro Therapeutics Inc, Dba Ev3 Neurovascular: 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.
- Recall number
- Z-2045-2013
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-07-19
- Posted
- 2013-08-23
- Terminated
- 2013-10-17
- Reason
- 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 "
- Root cause
- Employee error
- Action
- Covidien sent an Customer Notification letter dated July 19, 2013, to all affected customers who received affected lots of Pipeline Embolization Device (PED). The customer notification letter informed the customers of the problems identified and the actions to be taken. Customer are instructed to reply and fax response form to Covidien Customer Service at (763) 398-7001. Customers are instructed that Customer Service will issue an RGA number for the return of the affected product back to Covidien. Customers are also instructed that upon receipt of a Returned Goods Authorization (RGA) number, to write the RGA number on the FEDEX slip and send the product back to: Covidien Attention: Product Recall 14005 13th Ave Plymouth, MN 55441 Prepaid and preaddressed FEDEX slips are enclosed for their convenience. Once Covidien receives the returned units, product replacement units will be shipped directly to customers. Local Covidien Neurovascular representative is also available to assist them in expediting the exchange of product. Customers with any questions, are instructed to call (949) 839-3700.
- Quantity
- 62 units
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P100018"]
- Product code
- OUT
- Firm FEI
- 3004904811
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28