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Arrive, Braided Transseptal Sheath
- Starting date:
- December 21, 2016
- Posting date:
- April 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63056
Reason
There is a potential for "a fragment of the sheath inner liner to come off during the insertion of the dilator during the preparation of the sheath prior to use."
Manufacturer received one complaint related to this issue, which did not result in patient injury. However, the risk for possible injury is a concern if the sheath is not properly flushed and tested with the dilator prior to use.
Affected products
Arrive, Braided Transseptal Sheath
Lot or serial number
- C1-08986
- C1-09102
- C1-09693
- C1-09862
- C1-09863
- C1-10041
- C1-11485
- C1-11852
Model or catalog number
- 990061-055
- 990061-070
- 990061-090
- 990061-120
- 990079-055
- 990079-070
- 990079-090
Companies
- Manufacturer
-
Oscor Inc.
3816 De Soto Boulevard
Palm Harbor
34683
Florida
UNITED STATES