# FDA recall Z-3011-2020

> **Irvine Biomedical Inc, a St. Jude Medical Co.** · Class II · device recall initiated 2020-08-24.

## 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

## Distribution

Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.

## Key facts

- **Recall number:** Z-3011-2020
- **Recalling firm:** Irvine Biomedical Inc, a St. Jude Medical Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-24
- **Report date:** 2020-09-30
- **Termination date:** 2023-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3011-2020

## Citation

> AI Analytics. FDA recall Z-3011-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3011-2020. Source: US FDA. Licensed CC0.

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