The Recall Desk
HighFDA (Devices)·Z-0816-2017·Announced 2016-12-28

Medtronic Arrive Braided Transseptal Sheath Recalled for Liner Fragmentation

Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner may come out 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 with a risk of harm (liner fragmentation) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Oscor, Inc. is recalling the Medtronic Arrive Braided Transseptal Sheath 10F (Catalog # 990079-070-000). The device is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

The recall was initiated due to a complaint that during the insertion of the dilator through the sheath, a fragment of the inner liner came out of the sheath prior to use. A total of 1,269 units 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 affected lots have expiration dates ranging from October 29, 2016, to October 16, 2018.

The recalled product

Product
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.
Manufacturer
Oscor, Inc.
Category
Medical Device — Cardiac Catheter
Hazard
Affected units
1,269

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: C1-08310 Exp. October 29
  • 2016
  • C1-08364 Exp. November 21
  • C1-08606 Exp. February 20
  • 2017
  • C1-08611 Exp. February 20
  • C1-08802 Exp. April 3
  • C1-08857 Exp. April 22
  • C1-09091 Exp. July 10
  • C1-09090 Exp. July 10
  • C1-09859 Exp. March 5
  • 2018
  • C1-09860 Exp. March 5
  • C1-09880 Exp. March 11
  • C1-09921 Exp. March 16
  • C1-10039 Exp. April 5
  • C1-10141 Exp. April 22
  • C1-10146 Exp. April 23
  • C1-10242 Exp. May 4
  • C1-10240 Exp. May 4

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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