Boston Scientific Corporation: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide including Puerto Rico Foreign: To be provided Quantity: 309 units Lot/code info: GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296

UPC codes

08714729979333

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.