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Pipeline Embolization Device (PED) recallZ-2045-2013 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · initiated Jul 19, 2013

Class II Terminated All recalls posted in August 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Micro Therapeutics Inc, Dba Ev3 Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 "

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2045-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 19, 2013
Posted by the FDA
Aug 23, 2013
Recalling firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Quantity
62 units
Product code
OUT
FDA submissions
P100018
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.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

292 devices cleared under P100018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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