Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 34 units of the Adelante Breezeway 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 high-risk medical device where a component failure (liner fragmentation) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Oscor, Inc. is recalling 34 units of the OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM sheath, Catalog # AB101218. This medical device is designed to facilitate the introduction of catheters to 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 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.
The specific lot numbers involved are C1-10984 (Exp. July 28, 2018), C1-10983 (Exp. July 28, 2018), C1-11198 (Exp. August 23, 2018), and C1-11200 (Exp. August 23, 2018). Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 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
- 34
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 (6)
- Lot #'s: C1-10984 Exp. July 28
- 2018
- C1-10983 Exp. July 28
- C1-11198 Exp. August 23
- C1-11200 Exp. August 23
- and C1-10984 Exp. July 28
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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