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1.5 mm Hydro LeMaitre Valvulotome (2016-08-01)
- Starting date:
- August 1, 2016
- Posting date:
- August 19, 2016
- 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-59864
Affected products
- 1.5 mm Hydro LeMaitre Valvulotome
Reason
This recall has been initiated due to reported issues of hoops failing to close when the device was actuated. In some cases this issue has been discovered in-use. There is the possibility that a malfunctioning device could damage the vessel upon withdrawal.
Affected products
A. 1.5 mm Hydro LeMaitre Valvulotome
Lot or serial number
Lot: ELVH1071VA, exp: 2020-07
Lot: ELVH1072V, exp:2020-07
Lot: ELVH1082V, exp:2021-01
Lot: ELVH1086V, exp:2021-02
Lot: ELVH1098V, exp: 2021-05
Lot: ELVH1100V, exp: 2021-05
Lot: ELVH1102V
Lot: ELVH1103V
Model or catalog number
1009-00
Companies
- Manufacturer
-
Lemaitre Vascular
63 Second Avenue
Burlington
01803
Massachusetts
UNITED STATES