CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating recalled
Microvention is recalling Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating. The recall was initiated on 2 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0990-2025
- FDA event ID
- 95962
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Dec 2024
- FDA classified
- 17 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 2 Dec 2024 | Recall initiated by company | |
| 17 Jan 2025 | Classified by FDA | +46 days |
| 29 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Where it was distributed
US: None OUS: China
Questions about this recall
Why was it recalled?
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Which lots are affected?
Lot # 0000629846/UDI: (01)00816777027634
Where was it sold?
US: None OUS: China
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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