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