FDA Device recall Z-2235-2021
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X by Cordis, citing the balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2235-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-19 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cordis |
| Distribution | US |
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Reason
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Identifiers
| code_info | Lot/Batch number 82219442 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2021%22
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