Recall Z-1613-2024— ROUTE 92 MEDICAL INC
Class I · Ongoing
Class I FDA medical device recall by ROUTE 92 MEDICAL INC, initiated 2024-03-08. It names one FDA 510(k) clearance: K190431. Product: Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.. Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
- Recalling firm
- ROUTE 92 MEDICAL INC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-08
- Firm location
- San Mateo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reason for recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.