070 Access System Gen 1Recalls & reported problems
Route 92 Medical · 070 Access System; Contains Tenzing 7 delivery catheter (00853799007541) and 070 Catheter (00853799007459) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 8, 2024Open, Classified
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1612-2024 · Root cause: Process control · FDA record ↗
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- CEREGLIDE SBC92122UGCerenovus, Inc. · Catheter, Percutaneous, Neurovasculature9 reports
- AXS VECTA 46 INC-11814-146Stryker Corporation · Catheter, Percutaneous, Neurovasculature5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.