CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Adelante Breezeway 8f C120¿ S61cm D66cm recalled by Oscor

Oscor is recalling Adelante Breezeway 8f C120¿ S61cm D66cm, distributed in 8 states. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #'s: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016

Quantity recalled21

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0793-2017
FDA event ID: 75785
Recalling firm: Oscor, Palm Harbor, FL
Classification: Class II
Status: Terminated
Recall initiated: 5 Oct 2016
FDA classified: 19 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Oct 2016	Recall initiated by company
19 Dec 2016	Classified by FDA	+75 days
28 Dec 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Product as listed by the FDA

OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Where it was distributed

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

California Florida Maryland Missouri North Carolina New Jersey Puerto Rico Texas

Questions about this recall

Why was it recalled?

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Which lots are affected?

Lot #'s: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

29 other products · FDA event 75785

This product is part of a recall event; the main page for the event is Adelante Breezway 10f Straight S79cm D84cm recalled by Oscor.

Reported	Class	Recall	Company	Reason	Where
28 Dec 2016	CLASS II	Adelante Breezway 10f Straight S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S79cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S61cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C90¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S61cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezway 8f Straight S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C55¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C70¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C55¿ S79cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10F C55¿ S61CM recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C90¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C55¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f Straight S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C120¿ recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f Straight S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C55¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C70¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C55¿ S61cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S79cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Breezeway 10f S60 recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S61cm recalled	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C55¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C120¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f C120¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C70¿ S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C120¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 10f Straight S61cm D66cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C90¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states
28 Dec 2016	CLASS II	Adelante Breezeway 8f C70¿ S79cm D84cm recalled by Oscor	Oscor	Other	8 states

More recalls from Oscor

All 39

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22 Jul 2026Device	CLASS I	Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
22 Jul 2026Device	CLASS I	Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
22 Jul 2026Device	CLASS I	Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
23 Feb 2022Device	CLASS II	Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor	Oscor	Other	PA, TN
7 Apr 2021Device	CLASS II	AngioDynamics SafeSheath Ultralite 10F recalled by Oscor	Oscor	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,212

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
30 Sep 2026Device	CLASS II	Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled	Olympus Corporation of the Americas	Other	PA
30 Sep 2026Device	CLASS II	Cardioroot Woven Collagen Coated Vascular Graft recalled	SAS Intervascular	Other	Nationwide
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states