AXIOS Stent and Electrocautery- Enhanced Delivery recall
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Why was AXIOS Stent and Electrocautery- Enhanced Delivery recalled?
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
GTIN: 08714729904595 Lot Numbers: 32891503, 32946481, 32966087, 32976911, 32986912, 32986913, 32986914, 32996152, 33004776, 33004777, 33004779, 33008425, 33527176, 33547873, 33559652, 33562171, 33568700, 33568705, 33568709, 33580106, 33686169, 33686170, 33686171, 33686172, 33996104, 33996109, 34006713, 34052770, 34052771, 34052772, 34052773, 34065575, 34065576, 34065577, 34065578, 34136366, 33008426, 33008427, 33013790, 33013791, 33038652, 33158792, 33161956, 33219664, 33219665, 33223921, 33223922, 33223925, 33233417, 33233418, 33233419, 33233460, 33233461, 33235723, 33487216, 33487218, 33489572, 33527175, 33686173, 33686174, 33765268, 33765269, 33765271, 33765272, 33765273, 33765274, 33766684, 33775698, 33813656, 33813657, 33813658, 33813659, 33825083, 33825084, 33825087, 33825091, 33873459, 33873923, 33881493, 33996102, 34136369, 34136370, 34142870, 34142871, 34144414, 34144416, 34251354, 34261613, 34261617, 34261618, 34261619, 34263374, 34271464, 34271465, 34276937, 34276938, 34277681, 34286615, 34286616, 34286617, 34286618, 34308441
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1144 units US; 60 units (OUS)
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)