The Recall Desk
HighFDA (Devices)·Z-0790-2017·Announced 2016-12-28

Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

Oscor, Inc. is recalling 156 units 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 involves a medical device with a structural defect (fragmentation) that poses a risk of harm during a cardiac procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Oscor, Inc. is recalling 156 units of the OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM sheath, Catalog # AB081040. 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 a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator. The affected units 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 patients should stop using the affected lots immediately. The specific lot numbers and expiration dates are listed in the structured product information. Users should contact Oscor, Inc. for further instructions or replacement.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 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 Catheter Sheath
Hazard
Affected units
156

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 (15)

  • Lot #'s: C1-09714 Exp. February 11
  • 2018
  • OR-04657 Exp. April 20
  • C1-10900 Exp. July 19
  • C1-10899 Exp. July 19
  • C1-11048 Exp. August 3
  • C1-11729 Exp. October 4
  • OR-04729 Exp. October 29
  • C1-12233 Exp. December 21
  • C1-12234 Exp. December 22
  • C1-09062 Exp. June 24
  • 2017
  • C1-11047 Exp. August 3
  • 2018 and C1-12234 Exp. December 22
  • 2018 2

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

Same manufacturer · Oscor, Inc.

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Same hazard · structural defect

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