FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 Gen 1Recalls & reported problems
Route 92 Medical · FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7; Contains Tenzing 7 Delivery Catheter (00853799007541) and FreeClimb 70 reperfusion catheter, 132cm (00853799007183) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853799007497), received between Mar 20, 2024 and Mar 20, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's 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, 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.
Reports received per month
Recalls naming this device
- Mar 8, 2024Class IOpen, Classified
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1611-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT HAD A LEFT ICA TERMINUS OCCLUSION. A FIRST PASS WITH FREECLIMB 70 REPERFUSION SYSTEM AND SYNCHRO SELECT STANDARD LEFT SOME RESIDUAL CLOT IN THE MID PORTION OF THE M1 SEGMENT. DURING THE SECOND PASS THE DEVICES WERE ADVANCED INTO MID M1 SEGMENT. TENZING 7 AND SYNCHRO WIRE WERE REMOVED AND ASPIRATION WAS PERFORMED THROUGH FREECLIMB 70 FOR ROUGHLY 1-2 MINUTES. FREECLIMB 70 CATHETER WAS RETRACTED INTO THE ZOOM 88 CATHETER AT THE HORIZONTAL PETROUS SEGMENT OF THE LEFT ICA. A CONTRAST INJECTION THROUGH THE ZOOM 88 CATHETER IDENTIFIED EXTRAVASATION AT LEFT M1 SEGMENT. A DISSECTION OCCURRED.
Patient problems: Vascular Dissection
MAUDE report 18944700 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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