Tenzing 7 Delivery CatheterRecalls & reported problems across all models
Route 92 Medical · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Tenzing 7 Delivery Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 2 models of Tenzing 7 Delivery Catheter by Route 92 Medical in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2023 and Feb 24, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tenzing 7 Delivery Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 8, 2024Open, Classified
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1613-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Tenzing 7 Delivery Catheter problems
Device problems
- Material Separation2
- Device Damaged by Another Device1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Tenzing 7 Delivery Catheter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tenzing 7 Delivery Catheter Gen 1Catheter, Percutaneous1 recall0 reports
- Tenzing 7 Delivery Catheter Gen 1Catheter, Percutaneous4 reports
Recent Tenzing 7 Delivery Catheter adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Device Damaged by Another Device
A 7F GUIDE SHEATH SEVERELY KINKED DURING USE MAKING WITHDRAWAL OF A FREECLIMB 70 CATHETER THROUGH THE GUIDE SHEATH DIFFICULT. THE KINKED SHEATH DAMAGED THE TIP OF THE FREECLIMB 70 CATHETER DURING WITHDRAWAL. A SUBSEQUENT CONTRAST INJECTION THROUGH THE GUIDE SHEATH EMBOLIZED THE DISTAL MARKER BAND FROM THE FREECLIMB 70 INTO THE A2 ARTERY. ONE ATTEMPT TO RETRIEVE THE MARKER BAND WITH THE FREECLIMB 54 AND A STENT RETRIEVER WAS UNSUCCESSFUL. THE MARKER BAND WAS NOT FLOW LIMITING SO IT WAS LEFT IN PLACE. DURING WITHDRAWAL INTO THE KINKED GUIDE SHEATH, THE DISTAL END OF THE FREECLIMB 54 WAS DAMAGED AND STRETCHED. PHYSICIAN ACKNOWLEDGED THAT CONSIDERABLE FORCE WAS REQUIRED TO RETRACT THE CATHETER(S) THROUGH THE KINKED SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437726 ↗MalfunctionNov 11, 2024Unraveled Material; Unraveled Material
PATIENT WAS SUFFERING FROM A STROKE WITH THE RIGHT INTERNAL CAROTID ARTERY BLOCKED. PHYSICIAN ADVANCED FREE CLIMB 70 UP INTO THE RICA AND BROUGHT IT TO M1 SEGMENT WITHOUT ANY ISSUE. AFTER CONNECTING THE ASPIRATION THE PHYSICIAN FELT RESISTANCE PULLING BACK THE CATHETER. THE PHYSICIAN COMPLETELY REMOVED THE SYSTEM FROM THE PATIENT AND FOUND THE CATHETER HAD UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20656752 ↗InjuryNov 11, 2024Material Separation; Material Separation
PATIENT WITH A MID-RIGHT M1 OCCLUSION. PENUMBRA BMX 96 SHEATH AND FREECLIMB 70 SYSTEM WERE USED AND ASPIRATION WAS INITIATED. CATHETERS WERE WITHDRAWN WITH SOME RESISTANCE, AND IT WAS FOUND THE FREECLIMB 70 TIP HAD SEPARATED. IMAGING SHOWED THE TIP EMBOLIZED TO THE ANTERIOR SEGMENT (A1/A2), BUT DID NOT CAUSE AN INFARCT AND BLOOD FLOW CONTINUED, THEREFORE REMOVAL WAS NOT ATTEMPTED. SECOND PASS WITH A NEW FREECLIMB 70 SYSTEM PERFORMED WITHOUT INCIDENT BUT UNSUCCESSFUL. THIRD PASS WITH A STENT RETRIEVER PERFORMED AND THE CLOT IN THE M1 WAS REMOVED. PHYSICIAN NOTED THE CLINICAL CONDITION OF THE PATIENT CONTINUED TO DETERIORATE FROM THE ORIGINAL INFARCT, AND THE EMBOLIZED TIP APPEARED TO HAVE NO CLINICAL IMPACT ON THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20656277 ↗MalfunctionSep 27, 2023Material Separation; Material Separation
TENZING 7 SEPARATED AT THE PROXIMAL MARKER INSIDE A PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE TENZING 7 WITH A SNARE AND THE PATIENT WAS FINE.
Patient problems: Foreign Body In Patient
MAUDE report 17822673 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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