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TEMPORARY TRANSCUTANOUS PACING LEAD SYSTEM (2016-06-17)
- Starting date:
- June 17, 2016
- Posting date:
- July 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59242
Affected products
A. TEMPORARY TRANSCUTANOUS PACING LEAD SYSTEM
Reason
Medtronic has identified a compliance issue with model 6416 temporary transvenous pacing lead system. The product is not compliant with section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patient's lead to a possible hazardous voltage.
Affected products
A. TEMPORARY TRANSCUTANOUS PACING LEAD SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6416-100
6416-100S
6416-140
6416-200
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES