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ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEMS (2017-11-09)
- Starting date:
- November 9, 2017
- Posting date:
- November 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65162
Affected products
A. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (STRAIGHT)
B. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (FLARED)
C. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (TAPERED)
Reason
Vascutek has received two complaints whereby a small section of the delivery system sheath became detached from the collar during deployment of the Anaconda Longer Leg Iliac Stent device from the delivery system. Should this occur users should refer to the bailout procedure in the instructions for use (IFU) to complete the deployment.
Affected products
A. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (STRAIGHT)
Lot or serial number
2002073780
2002099645
2002099742
2002123372
Model or catalog number
L12X160
L12X180
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
B. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (FLARED)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FL1213X150
FL1213X170
FL1215X150
FL1215X170
FL1217X150
FL1217X170
FL1219X150
FL1219X170
FL1221X150
FL1221X170
FL1223X150
FL1223X170
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR
C. ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (TAPERED)
Lot or serial number
2002224604
2002233717
2002241503
2002380298
Model or catalog number
TL1210X150
TL1210X170
Companies
- Manufacturer
-
VASCUTEK LIMITED A TERUMO COMPANY
NEWMAINS AVENUE
INCHINNAN, GREAT BRITAIN
PA4 9RR