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ROUTE 92 MEDICAL

23 adverse events · 14 clearances · 5 recalls · aggregated across 3 source records

Scorecard
Events per device across the 49-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.041

2 in the last 12 months

Higher volume than 90% of companies with 10+ devices

Recalls per device

0

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
49 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5Gen 1NRY008537990076885
FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7Gen 1NRY008537990074975
Tenzing 7 Delivery CatheterGen 1DQY NRY QJP008537990075414
088 Access SystemGen 1QJP008537990072753
8F Base Camp Sheath SystemGen 1.5DQY008537990074113
8F Base Camp Sheath SystemGen 1.5DQY008537990074043
Tenzing 7 Delivery CatheterGen 1DQY008537990075342
070 Access SystemGen 1QJP008537990074421
8F Base Camp System 2.0 90cmGen 2.0DQY QJP008537990079301
8F Base Camp system 2.0 80cmGen 2.0DQY QJP008537990077181
8F Base Camp system 2.0 80cmGen 2.0DQY QJP008537990077011
8F Base Camp system 2.0 90cmGen 2.0DQY QJP008537990077251
8F Base Camp system 2.0 90cmGen 2.0DQY QJP008537990077321
FreeClimb 54 reperfusion catheter, 125cmGen 1NRY008537990077941
FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5Gen 1NRY008537990076951
FreeClimb 54 reperfusion catheter, 148cmGen 1NRY008537990077871
FreeClimb 54 x 125 cm Access SystemGen 1QJP008537990076571
FreeClimb 54 x 125 cm CatheterGen 1QJP008537990076331
FreeClimb 54 x 148 cm Access SystemGen 1QJP008537990076401
FreeClimb 54 x 148 cm CatheterGen 1QJP008537990076261
HiPoint 70 reperfusion catheter with Tenzing 7Gen 1NRY008537990079471
HiPoint 88 reperfusion catheter with Tenzing 8Gen 1NRY008537990079611
070 ACCESS SYSTEM0
070 CatheterGen 1QJP008537990074590
088 ACCESS SYSTEM0
088 CatheterGen 1QJP008537990072820
088 x 125 cm Full Length Access SystemGen 1QJP008537990071450
088 x 125 cm Full Length CatheterGen 1QJP008537990070770
088 x 132 cm Full Length Access SystemGen 1QJP008537990071380
088 x 132 cm Full Length CatheterGen 1QJP008537990070600
Showing 1–30 of 49Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3016522967Route 92 Medical, Head QuartersSan Mateo, CA, US
3030088112Route 92 Medical, West JordanW Jordan, UT, US