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U.S. Department of Health and Human Services

Class 2 Device Recall Echelon 14, 45 Tip Shape

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  Class 2 Device Recall Echelon 14, 45 Tip Shape see related information
Date Initiated by Firm June 30, 2022
Create Date August 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-1556-2022
Recall Event ID 90622
510(K)Number K093750  K030688  
Product Classification Catheter, continuous flush - Product Code KRA
Product Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Code Information Lot # B177543 UDI: (00) 847536006270
Recalling Firm/
Micro Therapeutics, Inc.
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact Kelli Lynch
Manufacturer Reason
for Recall
Outer carton packaging of microcatheters were exposed to wet substance during transport.
FDA Determined
Cause 2
Under Investigation by firm
Action On June 30, 2022, Micro Therapeutics, Inc. issued a "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to affected customers. The recall notification ask consignees to take the following actions: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. 4. This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 5. Adverse reactions or quality problems experienced with this product should be reported to Medtronic and FDA MedWatch Adverse Event Reporting program via: " Medtronic Quality Assurance at rs.nvcomplaints@medtronic.com or call +1 (763) 514-4000 (Worldwide) " The FDA website (http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm) or call FDA at 1-800-FDA-1088.
Quantity in Commerce 8 units
Distribution US Nationwide Distribution: None OUS: Brazil
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = EV3 INC
510(K)s with Product Code = KRA and Original Applicant = MICRO THERAPEUTICS, INC.