Tenzing 7 Delivery Catheter Gen 1 (UDI 00853799007541)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00853799007541), 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).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, 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 CATHETERS WERE WITHDRAWN WITH SOME RESISTANCE, AND IT WAS FOUND THE FREECLIMB 70 TIP HAD SEPARATED.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 ↗