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U.S. Department of Health and Human Services

Class 2 Device Recall Headway 17 Microcatheter

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 Class 2 Device Recall Headway 17 Microcathetersee related information
Date Initiated by FirmDecember 02, 2024
Date PostedJanuary 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0990-2025
Recall Event ID 95962
510(K)NumberK101542 
Product Classification Catheter, percutaneous - Product Code DQY
ProductMicrovention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Code Information Lot # 0000629846/UDI: (01)00816777027634
FEI Number 3013556777
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information ContactTerrence Callahan
714-247-8159
Manufacturer Reason
for Recall		Sterility assurance; microcatheter inner packaging may contain incomplete seal.
FDA Determined
Cause 2		Packaging process control
ActionOn December 11, 2024, MicroVention Eurpose SARL dba Terumo Neuro intiated a "Urgent Medical Device Recall" via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory 2. Inform and forward recall notice 3. Return Product 4. Contact Quality Department 5. Replacement or Credit of returned devices 6. Adverse reaction or quality problems experienced with the use of this product may be reported to your local MicroVention Terumo Sales Representative or the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce107 units
DistributionUS: None OUS: China
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQY
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