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Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lu...

FDA Device Recall #Z-0087-2021 — Class I — August 25, 2020

Recall Summary

Recall Number Z-0087-2021
Classification Class I — Serious risk
Date Initiated August 25, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Vascular
Location Danvers, MA
Product Type Devices
Quantity 2356 units

Product Description

Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 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 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.

Lot / Code Information

Lot Numbers : GFCP2154 GFCR2591 GFCR2592 GFCS2156 GFCU2199 GFCV2587 GFCW1652 GFCW2431 GFCX2712 GFCY2997 GFDN0246 GFDN3553 GFDN3554 GFDN3555 GFDP2922 GFDQ2500 GFDR2919 GFDS2209 GFDS2210 GFDT2188 GFDT2189 GFDT2204 GFDT2205 GFDU2170 GFDU2171 GFDV2179 GFDV2180 GFDV2181 GFDW2390 GFDW2391 GFDW2392 GFDX2711 GFDX2712 GFDY1135 GFDY1136 GFDZ1692 GFDZ1693 GFEP1181 GFEP1182 GFEP1183 GFEP1184 GFER2080 GFER2081

Other Recalls from Medtronic Vascular

Recall # Classification Product Date
Z-1860-2021 Class I Angiographic Guidewire Component: Model Number:... May 4, 2021
Z-1245-2021 Class II Medtronic 6F Launcher Guide Catheter 100 cmJL 3... Jan 15, 2021
Z-1246-2021 Class II Medtronic 6F Launcher Guide Catheter 100 cm JR... Jan 15, 2021
Z-1247-2021 Class II Medtronic 6F Launcher Guide Catheter 100cm EBU ... Jan 15, 2021
Z-1248-2021 Class II Medtronic 6F Launcher Guide Catheter 100 cm EBU... Jan 15, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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