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U.S. Department of Health and Human Services

Class 2 Device Recall AngioJet Spiroflex Thrombectomy Set

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  Class 2 Device Recall AngioJet Spiroflex Thrombectomy Set see related information
Date Initiated by Firm July 31, 2015
Date Posted August 13, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall Number Z-2377-2015
Recall Event ID 71849
510(K)Number K072769  
Product Classification Catheter, embolectomy - Product Code DXE
Product AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
Code Information 163580
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
763-494-1556
Manufacturer Reason
for Recall		 AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
FDA Determined
Cause 2		 Process control
Action Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.
Quantity in Commerce total of 9 units
Distribution Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
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 = DXE and Original Applicant = POSSIS MEDICAL, INC.
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