Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling 215 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 involves a medical device with a structural defect (liner fragmentation) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Oscor, Inc. is recalling 215 units of the Medtronic Arrive Braided Transseptal Sheath 10F C90° S61CM D66CM Global (Catalog # 990061-090-000). 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 during the insertion of the dilator through the sheath, a fragment of the inner liner came out of the sheath prior to use. The affected lots are C1-08939 (Exp. May 19, 2017), C1-08985 (Exp. June 1, 2017), C1-09584 (Exp. January 18, 2018), and C1-10120 (Exp. April 17, 2018).
The products 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 the recalling firm for instructions on return or replacement.
The recalled product
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 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.
- Affected units
- 215
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: C1-08939 Exp. May 19
- 2017
- C1-08985 Exp. June 1
- C1-09584 Exp. January 18
- 2018
- and C1-10120 Exp. April 17
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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