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

Adelante Breezeway 8f C90¿ S61cm D66cm recalled by Oscor

Oscor is recalling Oscor Adelante Breezeway 8f C90¿ S61cm D66cm, distributed nationwide in the US. 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: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019

Quantity recalled30

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-0792-2017
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 C90¿ S61CM D66CM Catalog # AB081042 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

Nationwide California Florida Maryland Missouri North Carolina New Jersey Puerto Rico Texas

Questions about this recall

Is Adelante Breezeway 8f C90¿ S61cm D66cm recalled?

Yes. Oscor recalled Adelante Breezeway 8f C90¿ S61cm D66cm on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0792-2017.

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: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019

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

More recalls from Oscor

All 39

Reported	Class	Recall	Company	Reason	Where
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 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide