Microvention Headway Microcatheter Recall Due to Incomplete Packaging Seal
Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a sterility defect. While no illnesses or injuries have been reported, the incomplete seal represents a real risk of contamination in a device used in invasive procedures where sterile status is essential to prevent infection.
Plain-English summary
Microvention Inc. is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter with Hydrophilic Coating (REF: MC172150SX-CN), a sterile prescription medical device used in interventional procedures.
The recall was initiated due to a sterility assurance issue: inner packaging of affected units may contain incomplete seals. A compromised seal could allow contamination and compromise the device's sterile status, which is critical for patient safety during invasive vascular procedures.
Approximately 107 units are involved in this recall. The affected lot was distributed outside the United States, specifically to China, with no units distributed domestically. Healthcare providers and facilities that received devices from this lot should take appropriate action according to FDA guidance.
The recalled product
- Product
- Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
- Manufacturer
- MICROVENTION INC.
- Affected units
- 107
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 0000629846/UDI: (01)00816777027634
Distribution
Distribution scope not specified by the agency.
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