Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found 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 with a risk of harm (foreign material release) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Oscor, Inc. is recalling 186 units of the Medtronic Arrive Braided Transseptal Sheath 10F C120 S61CM D66CM Global (Catalog # 990061-120-000). 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 lots are C1-08466, C1-09857, C1-10215, and C1-11438, with expiration dates ranging from December 19, 2016, to September 16, 2018.
The 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. Healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 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
- 186
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 (6)
- Lot #'s: C1-08466 Exp. December 19
- 2016
- C1-09857 Exp. March 5
- 2018
- C1-10215 Exp. April 29
- and C1-11438 Exp. September 16
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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