The Recall Desk
HighFDA (Devices)·Z-0812-2017·Announced 2016-12-28

Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because an inner liner fragment was found during insertion. The recall covers 1,729 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a physical defect (liner fragmentation) in a medical device used for cardiac procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheath 10F units (Catalog # 990061-070-000) due to a defect where a fragment of the inner liner came out of the sheath prior to use. The issue was identified during the insertion of the dilator through the sheath.

A total of 1,729 units are affected by this recall. The products were distributed worldwide, including in the United States (California, New Jersey, Maryland, Texas, Florida, North Carolina, Missouri, and Puerto Rico) and internationally to Austria, Bolivia, Canada, Chile, Cyprus, Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Specific lot numbers and expiration dates are listed in the official recall record.

Healthcare providers and consumers should stop using these devices and contact Oscor, Inc. for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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.
Manufacturer
Oscor, Inc.
Category
Medical Device — Cardiac Catheter
Hazard
Affected units
1,729

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #'s: C1-08273 Exp. October 8
  • 2016
  • C1-08340 Exp. November 11
  • C1-08605 Exp. February 20
  • 2017
  • C1-08608 Exp. February 20
  • C1-08816 Exp. April 8
  • C1-08940 Exp. May 19
  • C1-09102 Exp. July 21
  • C1-09169 Exp. August 21
  • C1-09170 Exp. August 21
  • C1-09361 Exp. November 3
  • C1-09693 Exp. February 10
  • 2018
  • C1-09742 Exp. February 16
  • C1-09743 Exp. February 16
  • C1-09862 Exp. March 5
  • C1-09903 Exp. March 15
  • C1-10041 Exp. April 5
  • C1-10148 Exp. April 23

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 30 recalled by Oscor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

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