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NANOSTIM LEADLESS CARDIAC PACEMAKER (2017-11-17)
- Starting date:
- November 17, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-65350
Affected products
NANOSTIM LEADLESS CARDIAC PACEMAKER
Reason
As part of Abbott's post market surveillance and clinical trial monitoring processes, we have been made aware of docking button detachments that have occurred following implant or during attempted retrieval of Nanostim Leadless Cardiac Pacemaker (LCP) devices, model number S1DLCP. In all three cases that have occurred, there has been no impact to the electrical function (e.g., pacing, sensing, communication) and no clinical impact or symptoms resulting from the docking button detachment or exposed cables.
Affected products
NANOSTIM LEADLESS CARDIAC PACEMAKER
Lot or serial number
Not Applicable
Model or catalog number
S1DLCP
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES