FDA Device recall Z-2204-2026
Swan-Ganz Pacing Catheter, Models: D200F7
- FDA Device
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Swan-Ganz Pacing Catheter, Models: D200F7 by Becton Dickinson And, citing catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2204-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-08 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
Swan-Ganz Pacing Catheter, Models: D200F7;
Reason
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Identifiers
| code_info | Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2204-2026%22
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