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

Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S79cm recalled

Oscor is recalling Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S79cm D84cm Global, 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: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018 53

Quantity recalled991

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-0817-2017
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

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 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 Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S79cm D84cm Global recalled?

Yes. Oscor recalled Medtronic Arrive Braided Transseptal Sheath 10f C90¿ S79cm D84cm Global on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0817-2017.

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: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018 53

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.

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