The Recall Desk
HighFDA (Devices)·Z-0805-2017·Announced 2016-12-28

Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

Oscor, Inc. is recalling 110 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 high-risk medical device where a structural defect (liner fragmentation) poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Oscor, Inc. is recalling 110 units of the OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM sheath, Catalog # AB101078. 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 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 and consumers should stop using the affected devices immediately. The specific lot numbers and expiration dates for the recalled units are listed in the official FDA recall record Z-0805-2017.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 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
110

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 (14)

  • Lot #'s: C1-09848 Exp. March 4
  • 2018
  • C1-11207 Exp. August 24
  • C1-11249 Exp. August 30
  • C1-09099 Exp. July 15
  • 2017
  • C1-09407 Exp. November 24
  • C1-09848 Exp. March 4
  • C1-10382 Exp. May 17
  • C1-11207 Exp. August 24
  • C1-11249 Exp. August 30
  • OR-04730 Exp. October 29
  • C1-09099 Exp. July 15
  • 2017 and C1-09848 Exp. March 4

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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