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U.S. Department of Health and Human Services

Class 2 Device Recall Inquiry Steerable Diagnostic Catheter

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  Class 2 Device Recall Inquiry Steerable Diagnostic Catheter see related information
Date Initiated by Firm August 24, 2020
Create Date September 24, 2020
Recall Status1 Terminated 3 on July 31, 2023
Recall Number Z-3011-2020
Recall Event ID 86328
510(K)Number K961924  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
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.
Code Information GTIN: 05414734302975, Lot: 7397352
Recalling Firm/
Manufacturer		 Irvine Biomedical Inc, a St. Jude Medical Co.
2375 and 2382 Morse Ave
Irvine CA 92614-6234
For Additional Information Contact Frank Gomez,
818-493-2434
Manufacturer 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
FDA Determined
Cause 2		 Labeling mix-ups
Action On 08/24/2020, Abbott Urgent Medical Device Recall Notices started being distributed to consignees in person or via mail. Customers were advised to do the following: 1) Any remaining inventory from this affected lot should not be used. 2) Complete and return the Acknowledgment Form. 3) Return any remaining unused affected devices. Please pass this notice to all those who need to be aware of it within your organization and maintain a record of this notice along with a copy of the completed Acknowledgement Form to ensure effectiveness of this communication. Should you have questions about this issue or for order replenishment, please contact your local firm Representative or Support at 1-855-478-5833 (Option 1) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.
Quantity in Commerce 15 units
Distribution Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = IRVINE BIOMEDICAL, INC.
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