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Cloversnare 4-Loop Vascular Retriever (2014-07-14)
- Starting date:
- July 14, 2014
- Posting date:
- August 8, 2014
- 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-40819
Recalled products
- Cloversnare 4-Loop Vascular Retriever
Reason
We have received reports of instances where the snare loop has separated from the shaft of the device. The issue appears to be related to/caused when lateral forces are applied to the loop/shaft connection (e.g. In three reports, separation occurred after attempts by a user to reshape the tip of the device). The issue was uncovered during a customer complaint investigation.
Affected products
A. Cloversnare 4-Loop Vascular Retriever
Lot or serial number
- 4319577
- 4319579
- 4319581
- 4319583
Model or catalog number
- VRS-6.0-90
Companies
- Manufacturer
-
Cook Incorporated
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES