Z-1613-2024Class I

Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of...

Name: Z-1613-2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of...
Creator: Route 92 Medical Inc
Published: 2024-03-08
License: https://open.fda.gov/license/

Route 92 Medical, Head Quarters / initiated 2024-03-08 / Open, Classified / root cause: manufacturing process

FDA source

ROUTE 92 MEDICAL INC began a recall of Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature on 2024-03-08. FDA classified it as Class I and gives the reason as "Their is the potential for distal tip separation at the proximal marker band of the delivery catheters". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1613-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-08
Posted: 2024-04-24
Recalling firm: Route 92 Medical, Head Quarters
Product: Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Product code: DQY Catheter, Percutaneous
Reason for recall: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 12, 2024 Route 92, issued a Urgent Medical Device recall notification to affected consignees via Mail and EMail. Route 92 asked consignees to take the following actions: Ensure all of your SUMMIT MAX inventory including the affected 070 Reperfusion Systems is in a secure, quarantined location. 2. Complete the Acknowledgement Form in Attachment 2 and return to Route 92 Medical by one of the following methods: [email protected]/Standard Mail - Attention Line: Tenzing 7 fiedl action, 155 Bovet Road Suite 100, San Mateo, CA 94402 Please return the Acknowledgement Form even if you no longer have the product subject to this recall. 4. Immediately return any affected products with the specific lot numbers listed in Attachment 1 to the address above using the original shipping container or request a new shipping container and pre-printed shipping label by email. 5. Keep this notice until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the quarantined product subject to this recall and keep a copy for your records. 6. Separately, as part of SUMMIT MAX closure, you will be sending back your remaining SUMMIT MAX inventory if you haven t done so already.
Quantity in commerce: 200 units
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
Product codes and lots: UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1610-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1611-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1612-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1613-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1614-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24

Product code DQY

K190431Class IIRoute 92 Medical Delivery CatheterRoute 92 Medical, Inc. / cleared 2019-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)