—#183686

Product

Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 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.

FDA product code: DXF — Catheter, Septostomy
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134

Why it was recalled

Subsequent failure of catheters in the field and failed quality testing

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Vascular
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-08-25
Posted by FDA: 2020-10-16
Terminated: 2024-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183686. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.