Oscor, Inc.
FDA Regulatory Profile
Oscor, Inc. appears in FDA public data with 39 recalls — including 6 Class I (most serious) —, 49 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2680-2026, Class I) was initiated on June 10, 2026. Its most recent 510(k) clearance was granted on June 3, 2021.
Summary
- Total Recalls
- 39 (6 Class I)
- 510(k) Clearances
- 49
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2680-2026 | Class I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | June 10, 2026 |
| Z-2678-2026 | Class I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | June 10, 2026 |
| Z-2679-2026 | Class I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | June 10, 2026 |
| Z-0646-2022 | Class II | Destino Twist 14F (also branded as Guidestar 14F) | December 22, 2021 |
| Z-1329-2021 | Class II | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduc | March 10, 2021 |
| Z-0391-2019 | Class I | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree | September 26, 2018 |
| Z-2340-2017 | Class I | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Ser | March 31, 2017 |
| Z-2733-2017 | Class I | ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposab | March 31, 2017 |
| Z-0805-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the int | October 5, 2016 |
| Z-0790-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the intr | October 5, 2016 |
| Z-0799-2017 | Class II | OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the | October 5, 2016 |
| Z-0819-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is | October 5, 2016 |
| Z-0793-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the in | October 5, 2016 |
| Z-0808-2017 | Class II | OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the | October 5, 2016 |
| Z-0811-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 I | October 5, 2016 |
| Z-0810-2017 | Class II | OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the intro | October 5, 2016 |
| Z-0800-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the int | October 5, 2016 |
| Z-0795-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the intr | October 5, 2016 |
| Z-0796-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the intro | October 5, 2016 |
| Z-0815-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 | October 5, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210627 | Breezeway II | June 3, 2021 |
| K151951 | Destino Reach | September 22, 2015 |
| K143463 | IS4/DF4 Port Plug | March 19, 2015 |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | July 9, 2014 |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | April 17, 2014 |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | February 13, 2014 |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | January 8, 2014 |
| K130104 | GUIDEWIRE, PURSUER SERIES | June 13, 2013 |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | December 13, 2012 |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | December 13, 2012 |
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | August 29, 2012 |
| K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | June 29, 2012 |
| K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | October 20, 2010 |
| K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | January 13, 2010 |
| K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | June 4, 2009 |
| K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | November 14, 2008 |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | June 18, 2008 |
| K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | January 22, 2008 |
| K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | November 30, 2007 |
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | June 7, 2007 |