The Recall Desk
HighFDA (Devices)·Z-0796-2017·Announced 2016-12-28

Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

Oscor, Inc. is recalling 61 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The product was distributed in the US and internationally.

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 in the source text, the risk of harm from a foreign object fragment in a cardiac setting is significant, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Oscor, Inc. is recalling 61 units of the OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM sheath, Catalog # AB081046. 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 are identified by specific lot numbers and expiration dates, including OR-04632, OR-04692, C1-11635, and C1-09412.

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, the Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Healthcare providers should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 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
61

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 (7)

  • Lot #'s: OR-04632 Exp. March 10
  • 2018
  • OR-04632 Exp. March 10
  • OR-04692 Exp. July 16
  • C1-11635 Exp. September 29
  • and C1-09412 Exp. December 1
  • 2017

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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