Z-0990-2025Class II

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN...

Name: Z-0990-2025 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN...
Creator: Microvention Inc.
Published: 2024-12-02
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2024-12-02 / Open, Classified / root cause: packaging

FDA source

MICROVENTION INC. began a recall of Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 on 2024-12-02. FDA classified it as Class II and gives the reason as "Sterility assurance; microcatheter inner packaging may contain incomplete seal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0990-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-02
Posted: 2025-01-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Product code: DQY Catheter, Percutaneous
Reason for recall: Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 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 commerce: 107 units
Distribution: US: None OUS: China
Product codes and lots: Lot # 0000629846/UDI: (01)00816777027634

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0990-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0990-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

Product code DQY

K101542Class IIHeadway 17 Advanced MicrocatheterMicroVention, Inc. / cleared 2010-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)