Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de
Summary
The FDA issued a Class I for Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Us by ROUTE 92 MEDICAL INC. Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Details
Source
Device Recall
External ID
Z-1613-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Lot/Code Info: UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707
Quantity Affected: 200 units
Reason for Recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Distribution
US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-08
Company
San Mateo, 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 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ROUTE 92 MEDICAL INC has 12 FDA actions in our database, including 5 recalls and 7 clearances.
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 (ROUTE 92 MEDICAL INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ROUTE 92 MEDICAL INC have FDA actions?
ROUTE 92 MEDICAL INC has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1613-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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