Rashkind Balloon Septostomy Catheter — Class I medical device recall Z-0088-2021
Terminated recall by Medtronic Vascular, reported 2020-10-28, distributed nationwide. Subsequent failure of catheters in the field and failed quality testing
| Recall number | Z-0088-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2020-08-25 |
| Classified | 2020-10-16 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-04-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BB, BE, BG, CA, CH, CZ, DE, DZ, ES, FI, FR, GB, GR, HR, HU, IE, IL, IN, IT, JP, LB, LV, MA, MY, NL, NO, NZ, OM, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TN, ZA |
| Quantity | 711 units |
| UPC / GTIN / UDI-DI | 00613994760265 |
| Lot numbers | GFCT1699, GFCT2030, GFCW2430, GFCX2784, GFCY2476, GFCY3001, GFDN0247, GFDN3546, GFDR2901, GFDT2170, GFDT2200, GFDU2168, GFDV2177, GFDW2388, GFDW2389, GFDW2399, GFDX2709, GFDY1132, GFDZ1690, GFDZ1691, GFEN2173 |
Product
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.
Reason for recall
Subsequent failure of catheters in the field and failed quality testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0088-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.