The Recall Desk
HighFDA (Devices)·Z-0811-2017·Announced 2016-12-28

Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation

Oscor, Inc. is recalling 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 is classified as FDA Class II and involves a risk-of-harm product (fragmentation) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Oscor, Inc. is recalling 566 units of the Medtronic Arrive Braided Transseptal Sheath 10F (Catalog # 990061-055-000). 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 devices 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, the Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. The recall covers specific lot numbers with expiration dates ranging from February 2017 to May 2019.

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

The recalled product

Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 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.
Manufacturer
Oscor, Inc.
Category
Medical Device — Cardiac Catheter
Hazard
Affected units
566

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 (14)

  • Lot #'s: C1-08604 Exp. February 20
  • 2017
  • C1-08938Exp. May 19
  • C1-08986 Exp. June 1
  • OR-04488 Exp. June 30
  • C1-09756 Exp. February 18
  • 2018
  • C1-09757 Exp. February 18
  • OR-04633 Exp. March 10
  • C1-10118 Exp. April 17
  • C1-10119 Exp. April 17
  • C1-10147 Exp. April 23
  • and C1-12525 Exp. May 17
  • 2019

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 →

Related recalls

Same manufacturer · Oscor, Inc.

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Same hazard · fragmentation

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