Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3011-2020·Announced 2020-09-30

Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

Irvine Biomedical is recalling 15 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and batch numbers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to procedure delays, fitting the criteria for moderate severity without reported injuries or fatalities.

Plain-English summary

Irvine Biomedical Inc, a St. Jude Medical Co., is recalling 15 units of Inquiry Steerable Diagnostic Catheters, Model IBI-81104, Lot 7397352. The recall was initiated because the packages were incorrectly labeled; some packages labeled as Model IBI-81104, batch 7397352 actually contained Model IBI-87002, batch 7397307, and vice versa.

The affected catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. If physicians fail to observe the difference between the catheter models, the intracardiac electrograms recorded may not be representative of the desired signals, which could result in a delay of the medical procedure.

The affected units were distributed worldwide, including nationwide distribution in the United States to the states of Missouri, Indiana, Wisconsin, Texas, Arizona, Michigan, Virginia, and Kentucky, as well as to Japan. Healthcare providers should verify the model and batch numbers of their catheters against the recall notice and contact the manufacturer for instructions on how to proceed.

The recalled product

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…
Manufacturer: Irvine Biomedical Inc, a St. Jude Medical Co.
Category: Medical Device — Cardiac Catheter
Hazard: mis-labeling
procedure-delay
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

GTIN: 05414734302975
Lot: 7397352

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Irvine Biomedical Inc, a St. Jude Medical Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Irvine Biomedical Inc, a St. Jude Medical Co.

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High
Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error
FDA (Devices) · 2020-09-30

Same hazard · mis labeling