Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.
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 device failure during a high-risk procedure places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Oscor, Inc. is voluntarily recalling eight units of the OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM sheath, Catalog # AB101075. 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. This defect could compromise the integrity of the device during a medical procedure.
The affected units are identified by Lot # C1-12145 (Exp. November 29, 2018), Lot # C1-08466 (Exp. December 19, 2016), and Lot # OR-04823 (Exp. June 16, 2019). These products were 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 these specific units and contact Oscor, Inc. for further instructions.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 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
- 8
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: C1-12145 Exp. November 29
- 2018
- C1-08466 Exp. December 19
- 2016 and OR-04823 Exp. June 16
- 2019
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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