CLASS I ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Tenzing 7 Delivery Catheter recalled by Route 92 Medical
Route 92 Medical is recalling Tenzing 7 Delivery Catheter, distributed in 26 states. The recall was initiated on 8 Mar 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1613-2024
- FDA event ID
- 94270
- Recalling firm
- Route 92 Medical, San Mateo, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Mar 2024
- FDA classified
- 24 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Mar 2024 | Recall initiated by company | |
| 24 Apr 2024 | Classified by FDA | +47 days |
| 1 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Product as listed by the FDA
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Where it was distributed
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
AlabamaArizonaCaliforniaFloridaGeorgiaIowaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNew JerseyNew YorkPennsylvaniaRhode Island
Questions about this recall
Why was it recalled?
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Which lots are affected?
UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 94270This product is part of a recall event; the main page for the event is 070 Access System recalled by Route 92 Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 070 Access System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states | |
| CLASS I | Full Length 070 Reperfusion System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states | |
| CLASS I | Full Length 070 Access System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states | |
| CLASS I | 070 Reperfusion System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states |
More recalls from Route 92 Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | 070 Reperfusion System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states |
| Device | CLASS I | Full Length 070 Access System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states |
| Device | CLASS I | Full Length 070 Reperfusion System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states |
| Device | CLASS I | 070 Access System recalled by Route 92 Medical | Route 92 Medical | Other | 26 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |