Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 74 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The device is used to introduce catheters to heart chambers.
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. While no injuries are reported, the risk of harm from a foreign object fragment during a high-risk procedure places this in the High severity category.
Plain-English summary
Oscor, Inc. is recalling 74 units of the OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM (Catalog # AB101076) medical device. This product 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 due to a complaint 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 C1-12572, C1-10896, C1-12139, C1-09133, C1-09943, and OR-04641.
The devices 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, 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 BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 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
- 74
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 (11)
- Lot #'s: C1-12572 Exp. June 17
- 2019
- C1-10896 Exp. July 16
- 2018
- C1-12139 Exp. November 24
- C1-12572 Exp. June 17
- C1-09133 Exp. August 3
- 2017
- C1-09943 Exp. March 19
- OR-04641 Exp. March 26
- and C1-10896 Exp. July 16
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.
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