Devices

Device Recall NC Stormer Zipper MX Balloon Dilation Catheter

Model / Serial
1) PMA # P790017/S79 2) Device Listing Number 2112641 3) Facility Registration number 2953200 4) lot codes 44DOE015, 44DOE016, 44DOE019, 44DOE022, 44DOE023, 44DOE020, 44DOE024, 44DOE025, 44DOE026, 44DOE021, 44DOE029, 44DOE032 5) Item numbers NCS2506ZP, NCS3016ZP, NCS2511ZP, NCS3516ZP, NCS3511ZP, NCS3521ZP, NCS3006ZP, NCS3011ZP, NCS2516ZP, NCS4006ZP, NCS4011ZP, NCS3021ZP
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to 40 hospitals
Product Description
Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
Manufacturer
Medtronic Vascular
1 Event
- Recall of Device Recall NC Stormer Zipper MX Balloon Dilation Catheter

Manufacturer

Medtronic Vascular

Manufacturer Address
Medtronic Vascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
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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