Devices

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead

Model / Serial
serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution: to USA and Europe, through distributor in MN.
Product Description
enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
Manufacturer
Greatbatch Medical
1 Event
- Recall of Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead

Manufacturer

Greatbatch Medical

Manufacturer Address
Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
Manufacturer Parent Company (2017)
Integer Holdings Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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