FDA Device recall Z-0088-2021
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashki…
- FDA Device
- Class I
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class I recall of Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashki… by Medtronic Vascular, citing subsequent failure of catheters in the field and failed quality testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0088-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-08-25 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
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
Subsequent failure of catheters in the field and failed quality testing
Identifiers
| code_info | Lot Numbers : GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFD…Lot Numbers : GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFDT2200 GFDU2168 GFDV2177 GFDW2388 GFDW2389 GFDW2399 GFDX2709 GFDY1132 GFDZ1690 GFDZ1691 GFEN2173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2021%22
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