Route 92 Medical Reperfusion System Potential Catheter Tip Separation
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as an FDA Class I recall. Although no injuries or illnesses have been reported, the potential for device component separation in a critical interventional catheter meets the Severe threshold per FDA classification guidelines.
Plain-English summary
Route 92 Medical, Inc. is recalling the Full Length 070 Reperfusion System (REF: 7001), a sterile, single-use medical device used to introduce interventional devices into the neurovasculature.
The recalled devices have the potential for distal tip separation at the proximal marker band of the delivery catheters. This defect could compromise device performance during clinical use.
Approximately 750 units have been distributed across the United States and New Zealand. The affected lot numbers are: 223060102, 24010102, 23070501, 24010903, 23082802, 24011606, 23100404, 24012403, and 23110901.
Facilities that have received this device should identify units with the affected lot numbers and contact Route 92 Medical, Inc. for recall information and guidance.
The recalled product
- Product
- Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Hazard
- distal-tip-separation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI: 00853799007497/ Lot # 223060102
- 24010102
- 23070501
- 24010903
- 23082802 24011606
- 23100404
- 24012403
- 23110901
Distribution
Distributed in 30 states:
- 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
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