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Anastaflo Intravascular Shunt (August 13, 2013)
- Starting date:
- August 13, 2013
- Posting date:
- August 13, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35509
Reason
Through post market surveillance data review, Edwards Lifesciences has identified a potential health risk to patients undergoing by-pass surgery when an Anastaflo intravascular shunt is used. Edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. There have been no reports of injuries in any of these complaints.
Affected products
Anastaflo Intravascular Shunt (2013-08-13)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
IVS1512, IVS1530, IVS2012, IVS2030, IVS2512, IVS2530, IVS3030
Companies
- Manufacturer
- Not Applicable
- Date modified: