LifeStream Balloon Expandable Vascular Covered Stent (2018-10-29)
- Starting date:
- October 29, 2018
- Posting date:
- November 15, 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-68240
Affected products
LifeStream Balloon Expandable Vascular Covered Stent
Reason
The actual restenosis complaint rate (0.04%) was higher than the predicted FMEA rate of 0.01% due to inclusion of complaints from the BOLSTER trial. The purpose of the recall is to advise users of the restenosis rate and provide an update to the Instructions for Use (IFU) for the LifeStream Balloon Expandable Vascular Covered Stent to include BOLSTER clinical trial results.
Affected products
LifeStream Balloon Expandable Vascular Covered Stent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- LSM0800526
- LSM0800537
- LSM0800616
- LSM0800626
- LSM0800637
- LSM0800658
- LSM0800716
- LSM0800726
- LSM0800737
- LSM0800758
- LSM0800816
- LSM0800826
- LSM0800837
- LSM0800858
- LSM0800938
- LSM0800958
- LSM0801038
- LSM0801058
- LSM0801238
- LSM0801258
- LSM1350526
- LSM1350537
- LSM1350616
- LSM1350626
- LSM1350637
- LSM1350658
- LSM1350716
- LSM1350726
- LSM1350737
- LSM1350758
- LSM1350816
- LSM1350826
- LSM1350837
- LSM1350858
- LSM1350938
- LSM1350958
- LSM1351038
- LSM1351058
- LSM1351238
- LSM1351258
Companies
- Manufacturer
-
Clearstream Technologies, Ltd
Moyne Upper, Enniscorthy
Wexford
IRELAND