The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0791-2017·Announced 2016-12-28

Oscor Medical Sheath Recalled for Inner Liner Fragmentation During Insertion

Oscor, Inc. is recalling 87 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 is classified as FDA Class II, and the hazard involves a structural defect in a medical device used for cardiac procedures. While no injuries are explicitly reported in the source text, the risk of harm from a fragment detaching during a procedure places this in the High severity category.

Plain-English summary

Oscor, Inc. is recalling 87 units of the OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM sheath, Catalog # AB081041. 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 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 patients should stop using the affected devices immediately. The specific lot numbers and expiration dates for the recalled units are C1-12312 (Exp. January 18, 2019), OR-04686 (Exp. July 16, 2018), OR-04655 (Exp. April 20, 2018), and C1-10985 (Exp. July 28, 2018). Users should contact Oscor, Inc. for further instructions on returning or disposing of these devices.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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
87

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 (10)

  • Lot #'s: C1-12312 Exp. January 18
  • 2019
  • OR-04686 Exp. July 16
  • 2018
  • Exp. April 21
  • 2015
  • OR-04655 Exp. April 20
  • C1-10985 Exp. July 28
  • C1-12312 Exp. January 18
  • and OR-04655 Exp. April 20

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.

See all →

Same hazard · structural defect

See all →

Similar recalls