Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk
Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum severity score of 4. While no illnesses or injuries are explicitly reported in the source text, tip separation from an angiographic catheter during a diagnostic or therapeutic procedure represents a significant risk of harm in an invasive medical device context.
Plain-English summary
Cook Incorporated is recalling multiple lots of Beacon Tip 5.0 Fr Angiographic catheters due to a risk of tip separation. The catheters are designed to facilitate diagnostic and therapeutic procedures and are available in various configurations with different shaft lengths, tip curves, and some with hydrophilic coating.
The company identified that catheters supplied in the affected device lots may experience tip separation. This defect could occur during use of the device in clinical procedures. A total of 26,986 units across multiple product configurations and lot numbers have been identified as affected.
The recalled catheters were distributed worldwide. Affected lot numbers include those manufactured between February 2026 and May 2026. Patients or healthcare providers who have used or possess these devices should contact their healthcare provider or Cook Incorporated for guidance on next steps.
Cook Incorporated is the recalling firm. For specific lot numbers and product identifiers, healthcare facilities should refer to the detailed product information available through FDA or contact the manufacturer. Patients who may have received treatment with these catheters should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic…
- Manufacturer
- Cook Incorporated
- Affected units
- 26,986
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 (20)
- 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN)
- UDI: (01)00827002087965(17)260202(10)15881668 (product)
- (01)10827002087962(17)260202(30)5(10)15881668 (box)
- Lot Number 15881668
- UDI: (01)00827002087965(17)260219(10)15903001 (product)
- (01)10827002087962(17)260219(30)5(10)15903001 (box)
- Lot Number 15903001
- UDI: (01)00827002087965(17)260306(10)NS15932463 (product)
- (01)10827002087962(17)260306(30)5(10)NS15932463 (box)
- Lot Number NS15932463
- 2) HNBR5.0-35-100-P-NS-DAV (RPN) G08699 (GPN)
- UDI: (01)00827002086999(17)260411(10)16003554 (product)
- (01)10827002086996(17)260411(30)5(10)16003554 (box)
- Lot Number 16003554
- 3) HNBR5.0-35-100-P-NS-H1 (RPN) G08421 (GPN)
- UDI: (01)00827002084216(17)260314(10)15948423 (product)
- (01)10827002084213(17)260314(30)5(10)15948423 (box)
- Lot Number 15948423
- 4) HNBR5.0-35-100-P-NS-JB2 (RPN) G08809 (GPN)
- UDI: (01)00827002088092(17)260319(10)15953578 (product)
Distribution
Distribution scope not specified by the agency.
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