Medtronic Aptus Heli-FX Thoracic EndoAnchor System recall
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…
Why was Medtronic Aptus Heli-FX Thoracic EndoAnchor System recalled?
It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157
- 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…
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- 20 units
- Distribution
- US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
- Recall date
- October 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)