Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm June 01, 2017
Create Date July 09, 2019
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-2674-2017
Recall Event ID 77431
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below
UPN: M00547340
Code Information Lot Number: 19343209 Exp: 6/3 0/2018
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact SAME
508-382-9555
Manufacturer Reason
for Recall		 Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
FDA Determined
Cause 2		 Employee error
Action Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 BSCFieldActionCenter@bsci.com.
Quantity in Commerce 32 units
Distribution MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
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.
-
-