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Anaconda Stents (2017-10-03)
- Starting date:
- October 3, 2017
- Posting date:
- October 27, 2017
- 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-64942
Affected products
- ANACONDA STENT GRAFT SYSTEM ILIAC LEG
- ANACONDA STENT GRAFT SYSTEM AORTIC CUFF
- ANACONDA STENT GRAFT SYSTEM FLARED LEG
- ANACONDA STENT GRAFT ILIAC LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR)
- ANACONDA STENT GRAFT FLARED AND TAPERED LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR)
- ANACONDA STENT GRAFT SYSTEM ONE-LOK BIFURCATE BODY
- ANACONDA STENT GRAFT SYSTEM TAPERED LEG
Reason
The manufacturer is updating and consolidating the instructions for use (IFU) for the listed products. Included is a new bailout procedure for snapped/broken release wires in the Anaconda Stent Graft System IFU and a new caution in the deployment instructions for the Anaconda AAA Stent Graft System Aortic Cuff. In addition, three current IFUs/IFU supplements for the Anaconda ONE-LOK AAA Stent Graft System, Anaconda Iliac Stent Graft System, and Anaconda AAA Stent Graft System Aortic Cuff have been combined into one main IFU (part no. 301-179).
Affected products
-
ANACONDA STENT GRAFT SYSTEM ILIAC LEG
Lot or serial number
All lots
Model or catalog number
- L12 X 060
- L12 X 080
- L12 X 100
- L12 X 120
- L12 X 140
- L12X160
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
B. ANACONDA STENT GRAFT SYSTEM AORTIC CUFF
Lot or serial number
All lots
Model or catalog number
AEC23
AEC25
AEC28
AEC30
AEC32
AEC34
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
C. ANACONDA STENT GRAFT SYSTEM FLARED LEG
Lot or serial number
All lots
Model or catalog number
FL1213X080
FL1213X110
FL1213X130
FL1213X170
FL1215X080
FL1215X110
FL1215X130
FL1215X150
FL1215X170
FL1217 X 080
FL1217 X 110
FL1217 X 130
FL1217X150
FL1217X170
FL1219 X 085
FL1219 X 130
FL1219X150
FL1221 X 085
FL1221 X 110
FL1221 X 130
FL1221X150
FL1221X170
FL1223 X 110
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
D. ANACONDA STENT GRAFT ILIAC LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR)
Lot or serial number
All lots
Model or catalog number
L10X100
L12X060
L12X080
L12X100
L12X120
L12X140
L13X060
L13X120
L13X140
L15X080
L16X120
L16X140
L17X120
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
E. ANACONDA STENT GRAFT FLARED AND TAPERED LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR)
Lot or serial number
All lots
Model or catalog number
FL1213X080
FL1213X110
FL1213X130
FL1215X080
FL1215X110
FL1215X130
FL1217X080
FL1217X110
FL1217X130
FL1219X085
FL1219X130
FL1221X085
FL1221X110
FL1221X130
FL1223X110
TL1210X080
TL1210X130
TL1712X110
TL2112X085
TL2112X130
TL2312X090
TL2312X110
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
F. ANACONDA STENT GRAFT SYSTEM ONE-LOK BIFURCATE BODY
Lot or serial number
All lots
Model or catalog number
OLB23
OLB25
OLB28
OLB32
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
G. ANACONDA STENT GRAFT SYSTEM TAPERED LEG
Lot or serial number
All lots
Model or catalog number
TL1210X080
TL1210X130
TL1210X150
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR