Medical device manufacturer Cook Medical issues recall of catheters due to a defect tied to three reported cases of significant injury
Cook Medical Issues Second Recall of Beacon Tip 5Fr Angiographic Catheter
Cook Medical has issued a second recall for its Beacon Tip 5Fr angiographic catheter, following reports of catheter tip separation during patient procedures [1][2][3]. This recall, announced in July 2025, comes after the company faced similar issues in 2015 and 2016 [4].
The Food and Drug Administration (FDA) designated this recall as Class I, the most serious recall category for medical devices, due to the potential for serious injury or death if the device is used [1][2][3][5]. The FDA's recall notice highlights the risks of catheter fragmentation and embolization, which can lead to sepsis, vessel perforation, thrombosis, embolism, cardiac arrhythmia, and potentially death [1].
So far, three serious injuries have been reported, but no deaths [1]. Cook Medical has asked customers to immediately stop all distribution of the affected products and quarantine any unused devices [1]. The company has also urged customers to notify all relevant clinical staff and third parties to prevent further use [1][2].
Beacon Tip catheters are used to guide angiographic imaging of blood vessels during interventional procedures. Their failure through tip separation compromises patient safety by potentially allowing catheter fragments to embolize within the vascular system, causing severe complications [1][2].
Healthcare providers are encouraged to report adverse events or quality issues related to the device to the FDA’s MedWatch system to monitor ongoing safety concerns [1].
Summary Table:
| Aspect | Details | |----------------------------|-------------------------------------------------------------| | Device | Cook Medical Beacon Tip 5Fr Angiographic Catheter | | Recall Type | Class I (most serious) | | Recall Date | July 2025 (announced early July) | | Cause | Catheter tip separation before and during use | | Clinical Risks | Catheter fragmentation, embolization, sepsis, vessel perforation, thrombosis, embolism, arrhythmia, death risk | | Reported Injuries | 3 serious injuries, no deaths reported so far | | Manufacturer Actions | Removal from distribution, quarantine of inventory, notification to customers and third parties | | User Advisory | Stop use immediately, inspect inventory, report adverse events to FDA MedWatch |
This recall underscores the need for vigilance in monitoring device integrity during use and emphasizes the potential risks associated with device failure during vascular procedures [1][2][3].
The recall notice does not provide any new details about the process deviation by the specific operator causing the fault. Additionally, the recall notice does not specify any new incidents or field complaints since the initiation of the recall in May.
Previous Recall
In 2015 and 2016, Cook Medical recalled the same Beacon Tip catheter due to similar issues [4]. The company has not provided any updates regarding recent changes or developments in its lead management business. Furthermore, the recall notice does not provide information about the purchase licensing rights of any company for Cook's lead management business.
References: [1] FDA Recall Notice: Cook Medical Beacon Tip 5Fr Angiographic Catheter, July 2025. Link [2] Cook Medical Announces Voluntary Recall of Beacon Tip 5Fr Angiographic Catheter, July 2025. Link [3] Medscape Medical News: Cook Medical Recalls Beacon Tip Angiographic Catheter, July 2025. Link [4] Cook Medical Issues Recall for Beacon Tip 5Fr Angiographic Catheter, 2015. Link
- The second recall of Cook Medical's Beacon Tip 5Fr angiographic catheter was issued in July 2025, due to reports of catheter tip separation during patient procedures.
- The Food and Drug Administration (FDA) classified this recall as Class I, the most serious category for medical devices.
- The FDA's recall notice indicated potential risks like catheter fragmentation and embolization, which could lead to severe complications like sepsis, vessel perforation, thrombosis, embolism, arrhythmia, and death.
- Three serious injuries have been reported so far, but no deaths.
- Healthcare providers are encouraged to report adverse events or quality issues related to the device to the FDA's MedWatch system to monitor ongoing safety concerns.
- This recall emphasizes the need for stringent regulation and safety measures in the medical technology (medtech) industry to ensure patient safety.
- The recall and the accompanying safety concerns highlight the significance of AI and imaging analytics in detecting device issues, as well as the role of science and medical-conditions research in developing more reliable therapies and treatments.
