International Medical Devices Database

Manufacturer Address
Enpath Medical, Inc, 7452 W 78th St, Minneapolis MN 55439-2513
Source
USFDA
2 Events
- Recall of Device Recall AngelMed Guardian
- Recall of Device Recall Enpath

2 devices in the database

Device Recall AngelMed Guardian

Model / Serial
Model LA-001, Lot # W38932
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
CA, NJ, MN
Product Description
Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.

Device Recall Enpath

Model / Serial
Model 501204 - Lot W35696, Model 501205 - Lot # W39157, Model 501206 - Lot #s W38997, W39457, W39156, W39389, W39687, W39665. Model 501214 - Lot #s W38961, W39457, W39671, W39763, W40053, W40704, W41307.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
CA, NJ, MN
Product Description
Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.

2 manufacturers with a similar name

Learn more about the data here

Enpath Medical, Inc.

Manufacturer Address
Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
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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Enpath Medical, Inc

2 devices in the database

Device Recall AngelMed Guardian

Device Recall Enpath

2 manufacturers with a similar name

Enpath Medical, Inc.

BARD/Enpath Medical, Inc.