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U.S. Department of Health and Human Services

Class 2 Device Recall WALLSTENT Endoposthesis with UNISTEP Plus Delivery System

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 Class 2 Device Recall WALLSTENT Endoposthesis with UNISTEP Plus Delivery Systemsee related information
Date Initiated by FirmJuly 09, 2004
Date PostedAugust 13, 2004
Recall Status1 Terminated 3 on January 05, 2007
Recall NumberZ-1340-04
Recall Event ID 29560
510(K)NumberK992510 
Product Classification Prosthesis, Tracheal, Expandable - Product Code JCT
ProductWALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
Code Information 6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactMichelle Gudith
763-494-1194
Manufacturer Reason
for Recall		Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
FDA Determined
Cause 2		Other
ActionBoston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
Quantity in Commerce82 units (H965402100) aa7 units (H965402100)
DistributionInside the US only.
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.
510(K) Database510(K)s with Product Code = JCT
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