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U.S. Department of Health and Human Services

Class 1 Device Recall Imager II 5F Angiographic Catheter

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  Class 1 Device Recall Imager II 5F Angiographic Catheter see related information
Date Initiated by Firm February 11, 2020
Create Date March 25, 2020
Recall Status1 Open3, Classified
Recall Number Z-1555-2020
Recall Event ID 84886
510(K)Number K121694  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Imager II 5F Angiographic Catheters, 5 units per package.
Code Information a. Material Number (UPN) Outer Package: M001314051; Material Number (UPN) Inner Package: M001314050; GTIN: 8714729354871; Lot Numbers (Exp. Date): 134092 (23-Aug-2020), 134600 (12-Sep-2020);   b. Material Number (UPN) Outer Package: M001314061; Material Number (UPN) Inner Package: M001314060; GTIN: 8714729354888; Lot Numbers (Exp. Date): 134011 (20-Aug-2020);   c. Material Number (UPN) Outer Package: M001314141; Material Number (UPN) Inner Package: M001314140; GTIN: 8714729354963; Lot Numbers (Exp. Date): 133737 (10-Aug-2020);   d. Material Number (UPN) Outer Package: M001314341; Material Number (UPN) Inner Package: M001314340; GTIN: 8714729355168; Lot Numbers (Exp. Date): 139512 (12-Mar-2021);   e. Material Number (UPN) Outer Package: M001314581; Material Number (UPN) Inner Package: M001314580; GTIN: 8714729355403; Lot Numbers (Exp. Date): 134631 (13-Sep-2020);   f. Material Number (UPN) Outer Package: M001314591; Material Number (UPN) Inner Package: M001314590; GTIN: 8714729355410; Lot Numbers (Exp. Date): 132447 (13-Jun-2020);   g. Material Number (UPN) Outer Package: M001314661; Material Number (UPN) Inner Package: M001314660; GTIN: 8714729355489; Lot Numbers (Exp. Date): 132355 (8-Jun-2020);   h. Material Number (UPN) Outer Package: M001315151; Material Number (UPN) Inner Package: M001315150; GTIN: 8714729355892; Lot Numbers (Exp. Date): 132823 (26-Jun-2020), 133447 (13-Jul-2020), 133448 (16-Jul-2020), 134946 (25-Sep-2020)      
Recalling Firm/
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
Manufacturer Reason
for Recall
Potential for tip detachment of Imager II 5F Angiographic Catheters
FDA Determined
Cause 2
Environmental control
Action Boston Scientific notified customers on about 02/11/2020 via "Urgent Medical Device Removal" letter. Customers were informed that Boston Scientific has noticed an increase in the rate of tip detachment complaints involving the recalled devices. Instructions included to examine inventory and quarantine affected products, complete and return the Verification Form, return all affected devices to Boston Scientific, and notify customers if affected devices were further distributed.
Quantity in Commerce 6,130 Single Units (1,226 5-packs)
Distribution Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.