The Recall Desk
HighFDA (Devices)·Z-0797-2017·Announced 2016-12-28

Oscor Medical Device Recall for Sheath Liner Fragmentation

Oscor, Inc. is recalling 11 Adelante Breezeway sheaths 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 component failure occurred, but the source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Oscor, Inc. is recalling 11 units of the OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM (Catalog # AB081047) medical device. This 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 from lot numbers C1-09372 (expiring November 5, 2017), C1-10142 (expiring April 22, 2018), and OR-04728 (expiring October 21, 2018).

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 and facilities should stop using these specific units and contact the manufacturer for further instructions.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 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
11

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 (5)

  • Lot #'s: C1-09372 Exp. November 5
  • 2017
  • C1-10142 Exp. April 22
  • 2018 and OR-04728 Exp. October 21
  • 2018

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 · component failure

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