Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device used for cardiac procedures where a fragment detached, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Oscor, Inc. is recalling 16 units of the OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM sheath, Catalog # AB101078. This medical device is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
The recall was initiated after a complaint reported that a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator. The affected units are identified by Lot # OR-04725 (Exp. October 20, 2018), Lot # C1-10042 (Exp. April 5, 2018), and Lot # C1-11868 (Exp. October 20, 2018).
The products were distributed worldwide, including in the United States (California, New Jersey, Maryland, Texas, Florida, North Carolina, Missouri, and Puerto Rico) and internationally to Austria, Bolivia, Canada, Chile, Cyprus, Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Healthcare providers should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
- Manufacturer
- Oscor, Inc.
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #'s: OR-04725 Exp. October 20
- 2018
- C1-10042 Exp. April 5
- and C1-11868 Exp. October 20
Distribution
Part of a larger recall action
This product is one of 30 recalled by Oscor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 30 products in this recall →Related recalls
Same manufacturer · Oscor, Inc.
See all →- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit Recalled Due to Potential Leakage
FDA (Devices) · 2026-07-22
- HighDestino Twist and Guidestar Devices Recalled for Potential Threaded Component Separation
FDA (Devices) · 2022-02-23
- ModerateOscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal
FDA (Devices) · 2021-04-07
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02