CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S79cm recalled
Oscor is recalling Medtronic Arrive Braided Transseptal Sheath 10f C70¿ S79cm D84cm Global, distributed in 8 states. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.
Check your package
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-0816-2017
- 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
- 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¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 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
CaliforniaFloridaMarylandMissouriNorth CarolinaNew JerseyPuerto RicoTexas
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: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611 Exp. February 20, 2017, C1-08802 Exp. April 3, 2017, C1-08857 Exp. April 22, 2017, C1-09091 Exp. July 10, 2017, C1-09090 Exp. July 10, 2017, C1-09859 Exp. March 5, 2018, C1-09860 Exp. March 5, 2018, C1-09880 Exp. March 11, 2018, C1-09921 Exp. March 16, 2018, C1-10039 Exp. April 5, 2018, C1-10141 Exp. April 22, 2018, C1-10141 Exp. April 22, 2018, C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018, C1-10240 Exp. May 4, 2018, C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018, C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 2018
Where was it sold?
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
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 75785This product is part of a recall event; the main page for the event is Adelante Breezway 10f Straight S79cm D84cm recalled by Oscor.
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|---|---|---|---|---|---|
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