Boston Scientific Corporation: AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

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: 47 units Lot/code info: GTIN: 00191506008093 Lot Numbers: 33419782, 33477824, 34116467, 33419783, 33511487

UPC codes

00191506008093

Source

Official record: FDA (Device enforcement) ↗

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