IMPRA ePTFE Vascular Graft, IMPRA CARBOFLO ePTFE Vascular Graft, and DISTAFLO Bypass Graft (2018-10-05)
- Starting date:
- October 5, 2018
- Posting date:
- November 2, 2018
- 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-68160
Affected products
- IMPRA ePTFE Vascular Graft, Flex Small Beading or IMPRA ePTFE Vascular Graft, Flex Thinwall Small Beading
- DISTAFLO Bypass Graft, Flex Small Beading With Standard Cuff or DISTAFLO Bypass Graft, Flex Small Beading With Small Cuff
- DYNAFLO Bypass Graft, Flex Small Beading
- IMPRA CARBOFLO ePTFE Vascular Graft, Flex Small Beading
- IMPRA CARBOFLO ePTFE Vascular Graft, Flex Thinwall Small Beading
- IMPRA ePTFE Vascular Graft, Flex Thinwall Tapered Small Beading
Reason
To inform customers of a potential concern with tearing of the identified vascular grafts during beading removal and to remind customers to follow the beading removal technique described in the instructions for use to avoid graft damage during removal of the beading.
Affected products
A. IMPRA ePTFE Vascular Graft, Flex Small Beading or IMPRA ePTFE Vascular Graft, Flex Thinwall Small Beading
Lot or serial number
- VTAT0698
- VTBP0381
- VTBY0632
- VTCR0436
- VTZL0607
Model or catalog number
- F7006TWS
- F8008S
- F8008TWS
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES
B. DISTAFLO Bypass Graft, Flex Small Beading With Standard Cuff or DISTAFLO Bypass Graft, Flex Small Beading With Small Cuff
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DF6007SC
- DF8006SC
- DF8007SC
- DFM5006SC
- DFM6006SC
- DFM7006SC
- DFM8006SC
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES
C. DYNAFLO Bypass Graft, Flex Small Beading
Lot or serial number
VTZL0710
Model or catalog number
DNF6007SC
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES
D. IMPRA CARBOFLO ePTFE Vascular Graft, Flex Small Beading
Lot or serial number
- VTCQ0306
- VTZF0121
Model or catalog number
F7008SC
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES
E. IMPRA CARBOFLO ePTFE Vascular Graft, Flex Thinwall Small Beading
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- F5006TWSC
- F5008TWSC
- F8006TWSC
- F8007TWSC
- F8008TWSC
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES
F. IMPRA ePTFE Vascular Graft, Flex Thinwall Tapered Small Beading
Lot or serial number
VTZL0725
Model or catalog number
F70T74TWS
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
85281
UNITED STATES