The Recall Desk
SevereFDA (Devices)·Z-1902-2025·Announced 2025-06-25

Beacon Tip 5.0 Fr Angiographic Catheters Recalled for Potential Tip Separation

Cook Incorporated recalled Beacon Tip 5.0 Fr angiographic catheters because the catheter tip may separate during use. The recall affects 26,986 units distributed worldwide.

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: The FDA classifies this as a Class I recall. Per the severity rubric, FDA Class I recalls never fall below score 4 (Severe). Although no illnesses or injuries have been reported, the potential for harm from catheter tip separation during vascular procedures is significant.

Plain-English summary

Beacon Tip 5.0 Fr angiographic catheters manufactured by Cook Incorporated are being recalled. These catheters are designed to facilitate diagnostic and therapeutic vascular procedures and are available in various configurations with different shaft lengths and tip curves, some with hydrophilic coating.

Cook Medical identified that catheters in the affected device lots may experience tip separation during use. This defect could compromise device integrity and the success of the intended procedure.

The recall affects 26,986 units that were distributed worldwide. Multiple product configurations and lot numbers are included in this recall.

Healthcare facilities should immediately stop using affected catheters and verify inventory against the provided lot numbers. For information about device replacement or return, facilities and patients should contact Cook Incorporated.

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 coati
Manufacturer
Cook Incorporated
Category
Medical Device — Angiographic Catheter
Hazard
  • 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 (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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