Medtronic Vascular: Medical Device Recall in 2020 - (Recall #: Z-0088-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: August 25, 2020

Date Posted: October 28, 2020

Recall Number: Z-0088-2021

Event ID: 86381

Reason for Recall:

Subsequent failure of catheters in the field and failed quality testing

Status: Terminated

Product Quantity: 711 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated