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VASCU-GUARD PERIPHERAL VASCULAR PATCH (2016-06-24)
- Starting date:
- June 24, 2016
- Posting date:
- August 9, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59738
Affected products
A. VASCU-GUARD PERIPHERAL VASCULAR PATCH
Reason
Baxter Healthcare is issuing a safety alert in response to postmarketing reports received for the Vascu-Guard Peripheral Vascular Patch for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. At this point, it is unknown whether there is any causal relationship between the device and the reported events.
Affected products
A. VASCU-GUARD PERIPHERAL VASCULAR PATCH
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- VG-0106N
- VG-0108N
- VG-0110N
- VG-0209N
Companies
- Manufacturer
-
Synovis Surgical Innovations
a Division of Synovis Life Technologies Inc.,
2575 University Avenue, suite 180
St-Paul
55114
Minnesota
UNITED STATES