# FDA recall Z-1613-2024

> **ROUTE 92 MEDICAL INC** · Class I · device recall initiated 2024-03-08.

## Product

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

## Distribution

US: AL	AZ	CA	DE	FL	GA	IA	IL	IN	KY	LA	MA	MD	MI	MN	MO	 NC ND	NJ	NY	OH	OR	PA	RI	SD	TN	TX	UT	VA	WV  OUS: New Zealand

## Key facts

- **Recall number:** Z-1613-2024
- **Recalling firm:** ROUTE 92 MEDICAL INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-08
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Mateo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2024

## Citation

> AI Analytics. FDA recall Z-1613-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1613-2024. Source: US FDA. Licensed CC0.

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