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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