The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,
Summary
The FDA issued a Class II for The C304-HIS device features a guide wire to access the vein, a valve to reduce by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility..
Details
Source
Device Recall
External ID
Z-1206-2022
Action Date
2022-06-08
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177
Quantity Affected: 1385 devices
Reason for Recall
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-20
Company
Mounds View, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have FDA actions?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1206-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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