Saturday, June 15, 2024

Route 92 Medical Issues Recall Due to Catheters Distal Tip Separation

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FDA issued a Class I recall for specific catheters manufactured by Route 92 Medical due to concerns regarding distal tip separation. The affected catheters include the Route 92 Medical 070 Access System, Tenzing 7 Delivery Catheter, Route 92 Medical 070 Reperfusion System, Route 92 Medical Full Length 070 Reperfusion System, and Route 92 Medical Full Length 070 Access System. These catheters are utilized for delivering microcatheters to brain blood vessels or as aspiration catheters for removing blood clots in patients with ischemic stroke.

The decision to instigate the recall stemmed from a series of reported incidents involving the detachment of the distal tip of the Tenzing 7 Delivery Catheters at the proximal marker band. Notably, these catheters were not produced in-house by Route 92 Medical but were instead manufactured by an external contract supplier. Upon conducting thorough investigations into the matter, it became evident that certain catheters manufactured by this supplier did not meet the rigorous quality standards established by Route 92 Medical. This discrepancy, particularly concerning the integrity of the proximal marker band, raised significant concerns regarding the safety and efficacy of the affected products.

Route 92 Medical Initiates Catheters Recall to Uphold Patient Safety and Quality Standards

In light of these findings, Route 92 Medical made the conscientious decision to take swift and decisive action by initiating a voluntary recall of the identified catheters. This proactive approach underscores the company’s unwavering commitment to patient safety and its dedication to upholding the highest standards of quality assurance in the medical device industry. By promptly addressing potential issues and swiftly implementing corrective measures, Route 92 Medical aims to mitigate any risks associated with the use of its products and safeguard the well-being of patients and healthcare professionals alike.

Furthermore, the decision to recall the affected catheters underscores Route 92 Medical’s steadfast adherence to regulatory guidelines and commitment to transparency in its operations. By proactively identifying and addressing issues, the company demonstrates its commitment to accountability and integrity, fostering trust and confidence among stakeholders. This recall serves as a testament to Route 92 Medical’s unwavering dedication to prioritizing patient safety above all else and its willingness to take decisive action in the face of potential risks or shortcomings in product quality.

Catheters

Announcing Urgent Recall of Catheters Due to Safety Risks and Regulatory Compliance

It’s imperative to note that the voluntary recall underscores Route 92 Medical’s commitment to proactively addressing any potential safety concerns associated with its products. By swiftly identifying and addressing issues, the company aims to ensure the ongoing safety and well-being of patients while upholding the highest standards of quality and regulatory compliance in the medical device industry.

Using catheters with a broken tip may result in surgical delays and pose risks to blood vessels. If the broken tip remains in the body, it can lead to the embolization of catheter fragments. Notably, there have been reports of two injuries and one death associated with this issue. Route 92 Medical issued an urgent field safety notice to all affected customers, instructing them to inspect their inventory for any affected products. If any affected product is found, it must be returned to a designated site in San Mateo, CA.

The recalled catheters are identified by various model numbers, including K190431 for the Route 92 Medical Delivery Catheter (Tenzing 7), K203043 for the Route 92 Medical 070 Access System, K222743 for the Route 92 Medical Full Length 070 Access System, K223530 for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, and G210002 for the Route 92 Medical 088 Reperfusion System, Route 92 Medical 070 Reperfusion System, and Route 92 Medical Aspiration Tubing Set in the SUMMIT MAX trial. These catheters were distributed between April 10, 2023, and February 29, 2024.

 

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Resource: Food and Drug Administration, May 10, 2024

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