# FDA recall Z-0089-2021 > **Medtronic Vascular** · Class I · device recall initiated 2020-08-25. ## 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. ## Reason for recall Subsequent failure of catheters in the field and failed quality testing ## 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. ## Key facts - **Recall number:** Z-0089-2021 - **Recalling firm:** Medtronic Vascular - **Classification:** Class I - **Product type:** device - **Status:** Terminated - **Initiation date:** 2020-08-25 - **Report date:** 2020-10-28 - **Termination date:** 2024-04-04 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Danvers, MA, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2021 ## Citation > AI Analytics. FDA recall Z-0089-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0089-2021. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*