Platinium DFR VR ICD, DR ICD, and SonR CRT-D (2018-03-16)
- Starting date:
- March 16, 2018
- Posting date:
- March 23, 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-66288
Affected products
A. Platinium DF4 VR ICD
B. Platinium DF4 DR ICD
C. Platinium DF4 SonR CRT-D
Reason
On a subset of Platinum ICD or CRT-D DF4 models, a component of the DF4 connector was identified as potentially defective leading to intermittent loss of contact. As a consequence, high values of continuity measures on the defibrillation coils or noise on the right ventricular channel may be observed. This issue can also lead to absence of ventricular pacing therapy and/or inappropriate shock. Delivery of defibrillation shock is unaffected.
Affected products
A. Platinium DF4 VR ICD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1240
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY
B. Platinium DF4 DR ICD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1540
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY
C. Platinium DF4 SonR CRT-D
Lot or serial number
650DD010
650DD0B2
650DD0F5
650DD151
650DD1C2
652DD02A
702DD04A
706DD09E
707DD04E
Model or catalog number
1841
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY