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NANOSTIM LEADLESS CARDIAC PACEMAKER
- Starting date:
- October 28, 2016
- Posting date:
- November 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60916
Affected Products
Reason
This recall has been initiated due to reports of lost telemetry and pacing output as a result of a battery malfunction associated with St. Jude Medical (SJM) Nanostim Leadless Cardiac Pacemaker (LCP) devices, Model No. S1DLCP. No patient injuries have been reported in association with the loss of bradycardia pacing therapy.
Affected products
NANOSTIM LEADLESS CARDIAC PACEMAKER
Lot or serial number
All lots.
Model or catalog number
S1DLCP
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES