CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Medtronic Arrive Braided Transseptal Sheath 10F C55¿ S61CM recalled
Oscor is recalling Medtronic Arrive Braided Transseptal Sheath 10F C55¿ S61CM D66CM GLOBALCatalog #, 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-0819-2017
- 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 C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 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: C1-12665 Exp. July 26, 2019
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.
More recalls from Oscor
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS II | Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor | Oscor | Other | PA, TN |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |