Oscor recalls
Oscor appears in 39 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 39 |
|---|---|
| Published | 2012-11-07 to 2026-07-22 |
| By agency | FDA Device (39) |
| By classification | Class II (33), Class I (6) |
| By status | terminated (35), ongoing (3), completed (1) |
| Distribution named in notices | AK, AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
FDA Device · Class I · 2026-07-22 · Oscor
Reason: 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. - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor
Reason: 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. - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor
Reason: 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. - Destino Twist 14F (also branded as Guidestar 14F)
FDA Device · Class II · 2022-02-23 · Oscor
Reason: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. - AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
FDA Device · Class II · 2021-04-07 · Oscor
Reason: Potential for open seal on sterile product - TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart
FDA Device · Class I · 2018-11-14 · Oscor
Reason: 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… - ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series
FDA Device · Class I · 2017-07-19 · Oscor
Reason: The Reusable Oscor ATAR extension cables could separate from the connector during use. - ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series
FDA Device · Class I · 2017-07-19 · Oscor
Reason: The Reusable Oscor ATAR extension cables could separate from the connector during use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introductio…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the hea…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the he…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the hea…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. - Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with…
FDA Device · Class II · 2012-11-07 · Oscor
Reason: Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out…