FDA Device recall Z-3011-2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophy…
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophy… by Irvine Biomedical A St Jude Medical, citing steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3011-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-24 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Irvine Biomedical A St Jude Medical |
| Distribution | US |
Product
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Reason
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay
Identifiers
| code_info | GTIN: 05414734302975, Lot: 7397352 |
|---|
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-3011-2020%22
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