The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0794-2017·Announced 2016-12-28

Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

Oscor, Inc. is recalling 991 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 risk-of-harm medical device where a component detached, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Oscor, Inc. is recalling 991 units of the OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM (Catalog # AB081044) 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 a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator. The affected lots include C1-12152, C1-09518, C1-09748, C1-09899, C1-10040, C1-10149, C1-10330, C1-10329, C1-10382, C1-11571, and OR-04757, with expiration dates ranging from December 2017 to December 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, 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 C55¿ S79CM D84CM Catalog # AB081044 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
991

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 (13)

  • Lot #'s: C1-12152 Exp. November 30
  • 2018
  • C1-09518 Exp. December 21
  • 2017
  • C1-09748 Exp. February 16
  • C1-09899 Exp. March 12
  • C1-10040 Exp. April 5
  • C1-10149 Exp. April 23
  • C1-10330 Exp. May 11
  • C1-10329 Exp. May 11
  • C1-10382 Exp. May 17
  • C1-11571 Exp. September 25
  • and OR-04757 Exp. December 22

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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