FDA Device recall Z-0089-2021
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 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, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 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-0089-2021 |
| 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, 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
Subsequent failure of catheters in the field and failed quality testing
Identifiers
| code_info | Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFD…Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134 |
|---|
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-0089-2021%22
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