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U.S. Department of Health and Human Services

Class 1 Device Recall Rashkind Balloon Septostomy Catheter

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  Class 1 Device Recall Rashkind Balloon Septostomy Catheter see related information
Date Initiated by Firm August 25, 2020
Date Posted October 16, 2020
Recall Status1 Open3, Classified
Recall Number Z-0088-2021
Recall Event ID 86381
Product Classification Catheter, septostomy - Product Code DXF
Product Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen
Product number: 007160
GTIN: 00613994760265

The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Code Information Lot Numbers :  GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFDT2200 GFDU2168 GFDV2177 GFDW2388 GFDW2389 GFDW2399 GFDX2709 GFDY1132 GFDZ1690 GFDZ1691 GFEN2173  
Recalling Firm/
Manufacturer
Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact Medtronic Customer Service
888-283-7868
Manufacturer Reason
for Recall
Subsequent failure of catheters in the field and failed quality testing
FDA Determined
Cause 2
Device Design
Action An immediate field corrective action was initiated by Medtronic field representatives. Customers were notified verbally to quarantine and return affected product on 25-Aug-2020. The following information was verbally provided to affected customers by Medtronic representative: "A supplier for Rashkind Catheter product has notified Medtronic that it has shipped product to Medtronic that may contain an issue. The supplier conducts a routine test in production. In two separate lots, the manufacturing specification was not met by all samples, but the lots were inadvertently shipped to Medtronic. We are requesting that you immediately refrain from using this product and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however this action is necessary to ensure the utmost patient safety with the use of our products" In the United States on 09-Sep-2020, Medtronic began delivering an "Urgent Medical Device Recall" letter via UPS 2- day delivery to risk managers who, according to Medtronic records have received affected product. The notification states the following: 1. Identify and quarantine all unused Rashkind Balloon Catheters as listed in notification 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-888-283-7868 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. 3. Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. Even if you do not have any product to return 4. Please forward the notice to all those who need to be aware within your organization.
Quantity in Commerce 711 units
Distribution Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Macedonia, Malaysia, Martinique, Moldova, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Tunisia, United Arab Emirates, and United Kingdom.
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.
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