Lower riskMedical device recall · FDA · Published December 2, 2024
Microvention Microcatheter Recall: Sterility Risk from Packaging Seal
Microvention recalls specific microcatheter models due to potential incomplete packaging seals that could compromise sterility. Affected units include lot #0000629846. Consumers should contact Microvention for details.
“Microvention Microcatheter Recall: Sterility Risk from Packaging Seal.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53372-microvention-microcatheter-recall-sterility-risk-from-packaging-seal. Based on FDA recall #Z-0990-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0990-2025%22&limit=1).
Microvention Inc. recalled the Microvention, Headway 17 Advanced Straight Microcatheter with Hydrophilic Coating due to sterility assurance issues, according to the FDA. The Food and Drug Administration announced the Class II recall on Dec. 2, 2024.
The microcatheter's inner packaging may contain an incomplete seal, compromising sterility assurance. The FDA described this as a Class II recall.
Context
GovInfoNow's records show Microvention Inc. has 15 other recalls on record since Aug. 7, 2017. Other recent recalls of similar products include the Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), the Microvention LVIS Stent Device Recall (April 6, 2026), and the Microvention Flow Re-Direction Devices recall (Sept. 5, 2025). Other recent recalls of similar products include Medline IV Start Kits Recalled Due to Sterility Risk in Packaging (June 12, 2026), Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), and Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (Jan. 7, 2026).
How to tell if you have this one
Check for the model number MC172150SX-CN, sterile packaging, and lot number 0000629846. This product was sold with the UDI (Unique Device Identification) code (01)00816777027634.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0990-2025 (December 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0990-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.