Medtronic Heli-FX Guide Catheter Recalled for Labeling Mismatch
Medtronic is recalling 20 units of the Heli-FX Guide 42 mm catheter because the deflection length on the handle does not match the box label.
What this means for you
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 source text identifies a labeling discrepancy without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Vascular, Inc. is recalling 20 units of the Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm (REF HG-18-90-42). The recall involves two specific lots: Lot Number 0008674156 (UDI 00763000006679) and Lot Number 0008674157 (UDI 00763000006655). The product is sterile, ethylene oxide sterilized, and prescription only.
The recall was initiated because the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging. This discrepancy affects the two identified lots.
The affected units were distributed in the United States to the states of Arizona, California, Florida, Georgia, Massachusetts, Michigan, Minnesota, and New Hampshire. Healthcare providers and facilities that have received these specific units should stop using them and contact Medtronic Vascular, Inc. for further instructions.
The recalled product
- Product
- Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for
- Manufacturer
- Medtronic Vascular, Inc.
- Hazard
- Affected units
- 20
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 (3)
- UDI 00763000006679
- Lot Number 0008674156 UDI 00763000006655
- Lot Number 0008674157
Distribution
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