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U.S. Department of Health and Human Services

Class 2 Device Recall NC Stormer Zipper MX Balloon Dilation Catheter

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 Class 2 Device Recall NC Stormer Zipper MX Balloon Dilation Cathetersee related information
Date Initiated by FirmJune 08, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 09, 2004
Recall NumberZ-1024-04
Recall Event ID 29326
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
ProductPercutaneous Transluminal Coronary Angioplasty system in sterile pouch.
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Vascular
3576 Unocal Pl
Santa Rosa CA 95403-1774
For Additional Information ContactBrad Ingersoll
707-543-2248
Manufacturer Reason
for Recall		medical device for which sterility may be compromised because of improper seal.
FDA Determined
Cause 2		Other
ActionA notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.
Quantity in Commerce193 units
DistributionProduct was distributed to 40 hospitals
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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