Angiodynamics Recalls Starburst MRI Electrode Devices Due to Marking Error
Angiodynamics is recalling 43 Starburst MRI Semi-Flex Electrode Devices because a printed distance mark is incorrectly located 4cm from the tip instead of 5cm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a minor labeling/marking error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Angiodynamics is recalling 43 units of the Starburst MRI Semi-Flex Electrode Device. The recall involves specific product and catalog numbers, including Product No. H7877001039091 and Catalog No. 700-103909, as well as Product No. H7877001026151 and Catalog No. 700-102615. The affected lots are 4773676, 4776428, and 4780110.
The recall was initiated because a printed mark on the trocar, intended to indicate a 5cm distance from the distal tip of the needle, is actually located 4cm from the distal tip. This discrepancy in the physical marking may affect the accuracy of the device's intended use.
The devices were distributed worldwide, including in the United States to the states of Arizona, Arkansas, Florida, Michigan, Minnesota, Missouri, New York, Texas, Virginia, Washington, and Wisconsin, as well as to Hungary and Spain. Users should stop using the affected devices and contact Angiodynamics for further instructions.
The recalled product
- Product
- Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
- Manufacturer
- Angiodynamics
- Category
- Medical Device — Electrode
- Hazard
- Affected units
- 43
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 (2)
- Lot No. 4773676
- 4776428 and 4780110
Distribution
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