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U.S. Department of Health and Human Services

Class 2 Device Recall IMAGER II Angiographic Catheters

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  Class 2 Device Recall IMAGER II Angiographic Catheters see related information
Date Initiated by Firm December 13, 2016
Date Posted March 23, 2017
Recall Status1 Terminated 3 on November 22, 2017
Recall Number Z-1781-2017
Recall Event ID 76002
510(K)Number K121694  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Code Information Lot: 00116127, Expiration Date: September 30, 2018
Recalling Firm/
Boston Scientific Corporation
2 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
Manufacturer Reason
for Recall
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
FDA Determined
Cause 2
Employee error
Action Customers were sent an Urgent Medical Device Removal letter, dated 12/5/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com
Quantity in Commerce 26 boxes of 5 (130 singles)
Distribution AZ, FL, MO, NJ, NY, OH, PA, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.