The Recall Desk
HighFDA (Devices)·Z-0799-2017·Announced 2016-12-28

Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

Oscor, Inc. is recalling 21 units of the Adelante Breezway 8F Straight 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 structural defect in a medical device used for cardiac procedures where a fragment detached. While no injuries are explicitly reported in the source text, the risk of harm from a foreign object in a cardiac procedure places this in the High category (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Oscor, Inc. is recalling 21 units of the OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM sheath, Catalog # AB081211. 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 identified by specific lot numbers and expiration dates, including C1-08988, OR-04708, C1-09373, and C1-11734.

The affected products 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 should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.

The recalled product

Product
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 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
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 (7)

  • Lot #'s: C1-08988 Exp. June 1
  • 2017
  • C1-08988 Exp. June 1
  • OR-04708 Exp. August 19
  • 2018
  • C1-09373 Exp. November 5
  • and C1-11734 Exp. October 5

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

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Same hazard · structural defect

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