Inquiry Steerable Diagnostic Catheter — Class II medical device recall Z-3011-2020
Terminated recall by Irvine Biomedical Inc, a St. Jude Medical Co., reported 2020-09-30, distributed nationwide. Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-
| Recall number | Z-3011-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Irvine Biomedical Inc, a St. Jude Medical Co., Irvine, CA, United States |
| Recall initiated | 2020-08-24 |
| Classified | 2020-09-24 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2023-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 15 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05414734302975 |
| Lot numbers | 7397352 |
| Model numbers | IBI-81104 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3011-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.