The Recall Desk
HighFDA (Devices)·Z-0793-2017·Announced 2016-12-28

Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

Oscor, Inc. is recalling 21 units of the Adelante Breezeway 8F sheath because a fragment of the inner liner detached during insertion. The product is distributed worldwide.

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 high-risk medical device (cardiac sheath) where a fragment detached during use. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Oscor, Inc. is recalling 21 units of the OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM sheath, Catalog # AB081043. 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 from Lot # C1-08337 (Expiration: November 7, 2016) and Lot # OR-4658 (Expiration: April 20, 2018).

The product was 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, Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Users should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 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
21

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: C1-08337 Exp. November 7
  • 2016
  • OR-4658 Exp. April 20
  • 2018
  • C1-08337 Exp. November 7
  • and C1-08337 Exp. November 7

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 →

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