The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0817-2017·Announced 2016-12-28

Oscor Recalls Medtronic Arrive Braided Transseptal Sheaths Due to Liner Fragmentation

Oscor, Inc. is recalling 991 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 detached during use, posing a risk of harm, 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 991 units of the Medtronic Arrive Braided Transseptal Sheath 10F (Catalog # 990079-090-000). 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 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 lots include C1-08341, C1-08607, C1-08803, C1-08941, C1-09173, C1-09394, C1-09531, C1-09718, C1-09748, C1-09899, C1-10040, C1-10149, C1-10330, C1-10329, C1-10382, C1-11571, and OR-04757.

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, the 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 C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 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
991

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: C1-08341 Exp. November 11
  • 2016
  • C1-08607 Exp. February 20
  • 2017
  • C1-08803 Exp. April 3
  • C1-08941 Exp. May 19
  • C1-09173 Exp. August 25
  • C1-09394 Exp. November 16
  • C1-09531 Exp. December 29
  • C1-09718 Exp. February 11
  • 2018
  • C1-09748 Exp. February 16
  • C1-09899 Exp. March 12
  • C1-10040 Exp. April 5
  • C1-10149 Exp. April 23
  • C1-10330 Exp. May 11
  • C1-10329 Exp. May 11
  • C1-10382 Exp. May 17
  • C1-11571 Exp. September 25
  • and OR-04757 Exp. December 22

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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