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Pulsar-18 Peripheral Self-Expanding Nitinol Stent System (2015-05-20)
- Starting date:
- May 20, 2015
- Posting date:
- June 12, 2015
- 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-53759
Recalled Products
A. Pulsar-18 Peripheral Self-Expanding Nitinol Stent System
Reason
Manufacturer received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of pulsar-18 peripheral self-expanding Nitinol Stent System
Affected products
A. Pulsar-18 Peripheral Self-Expanding Nitinol Stent System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
390681
390691
390701
390721
390741
Companies
- Manufacturer
-
Biotronik AG
Ackerstrasse Blvd 6
Bulach
8080
SWITZERLAND