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Autogen ICD and CRT-D ( 2014-11-17)
- Starting date:
- November 17, 2014
- Posting date:
- December 15, 2014
- 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-42861
Recalled Products
A) Autogen ICD
B) Autogen CRT-D
Reason
A patient may not receive effective pacing support until the RVAT test ends (i.e. Up to 20 cardiac cycles).
Affected products
A) Autogen ICD
Lot or serial number
Not applicable.
Model or catalog number
D046
D047
D176
D177
Companies
- Manufacturer
-
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES
B) Autogen CRT-D
Lot or serial number
Not applicable.
Model or catalog number
G172
G173
G175
G177
G179
Companies
- Manufacturer
-
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES