Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragment
Oscor, Inc. is recalling 45 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where a physical defect was reported, but no specific injuries or illnesses are documented in the source text.
Plain-English summary
Oscor, Inc. is recalling 45 units of the Medtronic Arrive Braided Transseptal Sheath 10F (Catalog # 990061-055-000). The recall is due to a complaint that a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator.
The affected products are from Lot # C1-12665 with an expiration date of July 26, 2019. These 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 FDA has classified this as a Class II recall. Healthcare providers and facilities should stop using the affected devices and contact Oscor, Inc. for further instructions.
The recalled product
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 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.
- Affected units
- 45
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 (2)
- Lot #'s: C1-12665 Exp. July 26
- 2019
Distribution
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.
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