Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, 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 22 units of the OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM (Catalog # AB101072). 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 identified by lot numbers C1-09396 (Exp. November 17, 2017) and C1-08804 (Exp. April 1, 2017).
The product was distributed worldwide, including in the United States (CA, NJ, MD, TX, FL, NC, MO, 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 further instructions.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 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
- 22
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 (5)
- Lot #'s: C1-09396 Exp. November 17
- 2017
- C1-09396 Exp. November 17
- C1-08804 Exp. April 1
- and C1-09396 Exp. November 17
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 Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
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 →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereBoston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
FDA (Devices) · 2024-05-22
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22
- SevereCardiac Catheters Recalled Due to Delamination and Device Malfunction
FDA (Devices) · 2024-05-22
- SevereBoston Scientific Cardiac Catheters Recalled for Material Delamination
FDA (Devices) · 2024-05-22
- HighOscor Recalls Myocardial Heart Wires Due to Spacing Defect
FDA (Devices) · 2012-11-07
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22