ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb
Summary
The FDA issued a Class I for ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use Cl by Inari Medical - Oak Canyon. Reason: Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, ca.
Details
Source
Device Recall
External ID
Z-2587-2024
Action Date
2024-08-28
Status
Ongoing
Category
device
Product Description
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Lot/Code Info: UDI-DI:00850291007277. All lots. IU-01011 REV. C.
Quantity Affected: 2488
Reason for Recall
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Distribution
Worldwide - US Nationwide distribution including in the states of PA, FL, GA, CA, IL, SC, NY, MN, UT, TN, WI, MI, KS, SD, AZ, AR, IN, KY, TX, AL, MS, DE, MA, OH, MO, WV, VA, NC, NV, CO, NE, OR, NM, NH, NJ, CT, ID, IA, WA, MD, OK, RI, DC, PR, LA, ND, VT and the countries of New Zealand, Chile, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-19
Company
Irvine, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Inari Medical - Oak Canyon has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Inari Medical - Oak Canyon) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inari Medical - Oak Canyon have FDA actions?
Inari Medical - Oak Canyon has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2587-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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