Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight 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 risk-of-harm product (medical device) where a component detached during use, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Oscor, Inc. is recalling 33 units of the OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM sheath, Catalog # AB101219. 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 during the insertion of the dilator through the sheath, a fragment of the inner liner came out of the sheath prior to use. The affected units are associated with specific lot numbers and expiration dates, including C1-11932, C1-08935, and C1-12448.
The product was 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, the Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Healthcare providers and facilities should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.
The recalled product
- Product
- OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 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
- 33
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 (8)
- Lot #'s: C1-11932 Exp. October 28
- 2018
- C1-08935 Exp. May 14
- 2017
- C1-11932 Exp. October 28
- C1-12448 Exp. April 14
- 2019
- and C1-12448 Exp. April 14
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