Oscor Recalls
39 recalls on record · November 7, 2012 to July 22, 2026 · Medical Devices
Recalls by year
12
16
17
18
21
22
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2026Medical DevicesFDA
Oscor Inc. recalls Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F.
Hazard: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
July 22, 2026Medical DevicesFDA
Oscor Inc. recalls Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F,
Hazard: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
July 22, 2026Medical DevicesFDA
Oscor Inc. recalls Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
Hazard: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
February 23, 2022Medical DevicesFDA
Oscor Inc. recalls Destino Twist 14F (also branded as Guidestar 14F)
Hazard: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
April 7, 2021Medical DevicesFDA
Oscor, Inc. recalls AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various type
Hazard: Potential for open seal on sterile product
November 14, 2018Medical DevicesFDA
Oscor, Inc. recalls TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right He
Hazard: During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
July 19, 2017Medical DevicesFDA
Oscor, Inc. recalls ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Di
Hazard: The Reusable Oscor ATAR extension cables could separate from the connector during use.
July 19, 2017Medical DevicesFDA
Oscor, Inc. recalls ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable
Hazard: The Reusable Oscor ATAR extension cables could separate from the connector during use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilit
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facili
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facil
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facil
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facil
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facil
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facili
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to faci
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facili
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of cat
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of cat
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of ca
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of cathe
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of cathete
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of cathet
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of cathet
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of cathe
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of cathet
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of cathete
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of cath
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
December 28, 2016Medical DevicesFDA
Oscor, Inc. recalls OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of cat
Hazard: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.