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Sonic - Braided Microcatheter With Progressive SupplenessSonic - Braided Microcatheter With Progressive Suppleness
- Starting date:
- July 6, 2017
- Posting date:
- August 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals
- Identification number:
- RA-64122
Reason
Balt Extrusion received complaints related to ruptures or inflations of sonic microcatheters during the injections of contrast liquid or embolic agents. Sonic microcatheters are designed to be thin and very flexible which allows them to reach very distal locations. Special attention must be given during the injections in order to avoid any complications related to overpressure. Hence, a customer letter was created and is being distributed to remind users to follow the instructions in the IFU to prevent incidents due to overpressure.
Affected products
Sonic - Braided Microcatheter With Progressive Suppleness
Lot or serial number
All lots
Model or catalog number
- SONIC 1.2F/15
- SONIC 1.2F/25
- SONIC 1.2F15SG
- SONIC 1.2F35
- SONIC 1.5F15
- SONIC 1.5F15SG
Companies
- Manufacturer
-
Balt Extrusion
10 Rue Croix-Vigneron
Montmorency
95160
FRANCE