Sam Brusco, Associate Editor05.10.24
Route 92 Medical’s recall of products containing Tenzing 7 delivery catheters that were distributed between April 10, 2023 and February 29, 2024 has been labeled Class I by the U.S. Food and Drug Administration (FDA).
The products affected in this recall include:
These catheters are used to deliver microcatheters to the neurovasculature or as aspiration catheters to remove blood clots in ischemic stroke patients.
The specific lots of catheters were recalled after reports of multiple instances of the distal tip separating at the proximal marker band. The company said these catheters weren’t manufactured by Route 92, but by an outside contract supplier.
Further investigation found the affected catheters made by the outside supplier didn’t meet Route 92’s quality standards—particularly in the area of the proximal band.
A broken catheter tip can delay surgery time, harm blood vessels, cause the broken tip to be left in the body, and lead to catheter fragment embolization. Two injuries have been reported, as well as one death due to the issue.
Route 92’s March 8 urgent field safety notice urged Tenzing 7 users to examine inventory, identify affected lots, and communicate the issue to anyone who might need to be informed. After completing an acknowledgment form, customers were advised to return affected products that are on site and arrange return for products forwarded to other healthcare facilities.
The products affected in this recall include:
- Route 92 Medical 070 access system
- Tenzing 7 delivery catheter
- Route 92 Medical 070 reperfusion system
- Route 92 Medical full length 070 reperfusion system
- Route 92 Medical full length 070 access system
These catheters are used to deliver microcatheters to the neurovasculature or as aspiration catheters to remove blood clots in ischemic stroke patients.
The specific lots of catheters were recalled after reports of multiple instances of the distal tip separating at the proximal marker band. The company said these catheters weren’t manufactured by Route 92, but by an outside contract supplier.
Further investigation found the affected catheters made by the outside supplier didn’t meet Route 92’s quality standards—particularly in the area of the proximal band.
A broken catheter tip can delay surgery time, harm blood vessels, cause the broken tip to be left in the body, and lead to catheter fragment embolization. Two injuries have been reported, as well as one death due to the issue.
Route 92’s March 8 urgent field safety notice urged Tenzing 7 users to examine inventory, identify affected lots, and communicate the issue to anyone who might need to be informed. After completing an acknowledgment form, customers were advised to return affected products that are on site and arrange return for products forwarded to other healthcare facilities.