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Perceval S Post-Dilation Catheter (2013-01-14)
- Starting date:
- January 14, 2014
- Posting date:
- February 10, 2014
- 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-37855
Recalled Products
Perceval S Post-Dilation Catheter
Reason
Sorin Group Italia has received one problem report regarding the Perceval S valve post dilation balloon catheter (Size M). After the post dilation procedure, the blue reference circle (Depth marker ring), which is intended to provide a reference to the surgeon to assure proper positioning of the valve, was found to be displaced on the catheter tip. This may occur when the plastic tube that protects the balloon is removed.
Affected products
Perceval S Post-Dilation Catheter
Lot or serial number
1306130204
1306170173
1307120139
1307290152
1309040047
1309190221
Model or catalog number
ICV1149
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY