The Recall Desk
HighFDA (Devices)·Z-0815-2017·Announced 2016-12-28

Medtronic Arrive Braided Transseptal Sheath Recalled for Fragment Release

Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

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 involves a medical device where a component fragment detached, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Oscor, Inc. is recalling 59 units of the Medtronic Arrive Braided Transseptal Sheath 10F (Catalog # 990079-055-000). The device is designed to facilitate the introduction of catheters to heart chambers, including the left atrium via a transseptal puncture.

The recall was initiated after a complaint reported that a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator. The affected units are from Lot C1-08936 (Exp. May 18, 2017) and Lot OR-04635 (Exp. March 10, 2018).

The devices were distributed worldwide, including in the United States (CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico) and internationally to Austria, Bolivia, Canada, Chile, Cyprus, Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Healthcare providers should stop using the affected devices and contact Oscor, Inc. for further instructions.

The recalled product

Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 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
59

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 (3)

  • Lot #'s: C1-08936 Exp. May 18
  • 2017 and OR-04635 Exp. March 10
  • 2018

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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