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Class 2 Device Recall SELECTSITE C304HIS Deflectable Catheter System |
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Date Initiated by Firm |
April 20, 2022 |
Create Date |
May 27, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1206-2022 |
Recall Event ID |
90101 |
510(K)Number |
K183493
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Product Classification |
Catheter, percutaneous - Product Code DQY
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Product |
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy. |
Code Information |
Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177 |
Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 8200 Coral Sea St Ne Mounds View MN 55112-4391
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For Additional Information Contact |
763-505-6000
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Manufacturer Reason for Recall |
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm sent out a recall notification starting on 04/20/2022 via UPS 2-day delivery. Customers are asked to return all unused affected product, share the notice with all those who need to be aware within their organization or with any organization where the above-listed products have been transferred, and to complete the response form. |
Quantity in Commerce |
1385 devices |
Distribution |
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Arab Emirates, United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = DQY and Original Applicant = Medtronic Inc.
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