Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error
Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (procedure delay and inaccurate diagnostic signals) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Irvine Biomedical Inc, a St. Jude Medical Co., is recalling 40 units of Inquiry Steerable Diagnostic Catheters. The recall involves a mix-up where packages labeled as Model IBI-81104, batch 7397352, incorrectly contained Model IBI-87002, batch 7397307. Conversely, packages labeled as Model IBI-87002, batch 7397307, incorrectly contained Model IBI-81104, batch 7397352.
The hazard associated with this recall is that if physicians fail to observe the difference between the catheter models, the intracardiac electrograms recorded may not be representative of the desired signals. This discrepancy could result in delays during diagnostic electrophysiology studies. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide distribution in the United States (specifically in MO, IN, WI, TX, AZ, MI, VA, and KY) and in Japan. Physicians and healthcare facilities should verify the model and lot numbers of the catheters in their inventory against the recall notice and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - 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.
- Affected units
- 40
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: 05414734309936
- Lot: 7397307
Distribution
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 →Related recalls
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