The Recall Desk
HighFDA (Devices)·Z-0801-2017·Announced 2016-12-28

Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

Oscor, Inc. is recalling specific lots of the Adelante Breezeway 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 is classified as FDA Class II, and the hazard involves a structural defect in a high-risk medical device used for cardiac procedures, which fits the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Oscor, Inc. is recalling the OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM (Catalog # AB101073) 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 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 # C1-09395 (Expiration: November 17, 2017) and Lot # C1-11621 (Expiration: November 2, 2018).

The affected products 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 lots and contact Oscor, Inc. for further instructions.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 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.
Category
Medical Device — Cardiac Catheterization
Hazard
Affected units
70

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 (3)

  • Lot #'s: C1-09395 Exp. November 17
  • 2017 and C1-11621 Exp. November 2
  • 2018

Distribution

Distributed in 8 states:

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

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Same hazard · structural defect

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