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

Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S61cm recalled

Oscor is recalling Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S61cm D66cm 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: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018

Quantity recalled1,729

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-0812-2017
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 C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 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 C70¿ S61cm D66cm Global recalled?

Yes. Oscor recalled Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S61cm D66cm Global on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0812-2017.

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: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018

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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