Lower riskMedical device recall · FDA · Published August 25, 2020
Medtronic Vascular Rashkind Balloon Septostomy Catheter Recall: Field Failures and Quality
Medtronic Vascular recalls pediatric Rashkind Balloon Septostomy Catheters (6F, 50 cm) due to field failures and failed quality testing. Affected lot numbers include GFCP2154 through GFDZ1693. Consumers should contact Medtronic for details.
“Medtronic Vascular Rashkind Balloon Septostomy Catheter Recall: Field Failures and Quality.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64428-medtronic-vascular-rashkind-balloon-septostomy-catheter-recall-field-failures-and. Based on FDA recall #Z-0087-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2021%22&limit=1).
The FDA announced on Aug. 25, 2020, that Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheters due to field failures and failed quality testing. The agency classified the recall as Class I.
How to tell if you have it
Brand: Medtronic Vascular
Product: Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen
The Rashkind balloon septostomy catheters are designed for creating or enlarging an atrial septal defect to treat patients with Cyanotic Congenital heart defects. The recall addresses subsequent failures of the catheters in the field and failed quality testing.
Context
GovInfoNow's records show Medtronic Vascular has five other recalls on record since March 13, 2018. Other recent recalls include a May 4, 2026 recall of Medline Medical Procedure Kits for catheter issues and an April 30, 2026 recall of Microvention Bobby Balloon Guide Catheters for balloon pinhole defects.
How to tell if you have this one
Check the product lot numbers listed: GFCP2154 through GFDZ1693. The catheters are pediatric, 6F size, 50 cm, with a recess balloon and closed end.
Brand
Medtronic Vascular
Product
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0087-2021
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.; 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
2356 units
Z-0088-2021
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.; Lot Numbers : GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFDT2200 GFDU2168 GFDV2177 GFDW2388 GFDW2389 GFDW2399 GFDX2709 GFDY1132 GFDZ1690 GFDZ1691 GFEN2173
711 units
Z-0089-2021
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.; Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134
505 units
Based on the official FDA remedy
What to do — step by step
Contact Medtronic
Reach out to Medtronic Vascular for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Indiana, Massachusetts, Michigan, North Carolina, Pennsylvania, Puerto Rico, Tennessee, Washington.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0087-2021 (August 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0087-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.