The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0804-2017·Announced 2016-12-28

Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

Oscor, Inc. is recalling 124 units of the Adelante Breezeway 10F sheath because a fragment of the inner liner detached during insertion. The product was distributed worldwide.

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 medical device defect where a fragment detached during use, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Oscor, Inc. is recalling 124 units of the OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM sheath, Catalog # AB101077. 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 identified by specific lot numbers and expiration dates ranging from February 2017 to January 2019.

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. Users should stop using the affected devices and contact Oscor, Inc. for further instructions.

The recalled product

Product
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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
124

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: C1-08611 Exp. February 20
  • 2017
  • C1-09397 Exp. November 17
  • C1-09408 Exp. November 25
  • C1-09861 Exp. March 5
  • 2018
  • C1-09858 Exp. March 5
  • C1-10901 Exp. July 19
  • C1-11205 Exp. August 24
  • C1-12250 Exp. January 4
  • 2019
  • C1-08611 Exp. February 20
  • and C1-11205 Exp. August 24

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 · device fragmentation

See all →

Similar recalls