Health product recall

Platinium SonR CRT-D (2018-07-09)

Starting date:
July 9, 2018
Posting date:
July 19, 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-67280

Affected products

Platinium SonR CRT-D

Reason

On a subset of Platinum ICD and CRT-D devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by loss of pacing and sensing capabilities in all cavities. As a result of the loss of sensing capability, the device cannot identify an arrhythmia that would require a defibrillation shock therapy.

Affected products

Platinium SonR CRT-D

Lot or serial number

641DL093
642DL0A8
644DL019
650DL05E
650DL169

Model or catalog number

1811

Companies
Manufacturer
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY