Class IOngoingZ-1902-2025

Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and ther…

Cook IncorporatedBloomington, IN, United StatesReported Jun 25, 2025 · 1 year ago

By Taylor Coteus

Legal News Analyst · Jun 25, 2025

Reason for recall

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).

Lot / code information

UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087962(17)260202(30)5(10)15881668 (box)
Lot #: 15881668; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN)
UDI: (01)00827002087965(17)260219(10)15903001 (product), (01)10827002087962(17)260219(30)5(10)15903001 (box)
Lot #: 15903001; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN)
UDI: (01)00827002087965(17)260306(10)NS15932463 (product), (01)10827002087962(17)260306(30)5(10)NS15932463 (box)
Lot #: 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 #: 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 #: 15948423; 4) HNBR5.0-35-100-P-NS-JB2 (RPN) G08809 (GPN)

Additional code information

0201(30)5(10)NS15877682 (box), Lot Number NS15877682; 58) HNBR5.0-38-65-P-NS-VS1 (RPN) G11486 (GPN), UDI: (01)00827002114869(17)260222(10)15912384 (product), (01)10827002114866(17)260222(30)5(10)15912384 (box), Lot Number 15912384; 59) HNBR5.0-38-80-P-NS-C1 (RPN) G11203 (GPN), UDI: (01)00827002112032(17)260328(10)15980162 (product), (01)10827002112039(17)260328(30)5(10)15980162 (box), Lot Number 15980162; 60) HNBR5.0-38-80-P-NS-CHG2.5 (RPN) G11430 (GPN), UDI: (01)00827002114302(17)260304(10)15928715 (product), (01)10827002114309(17)260304(30)5(10)15928715 (box), Lot Number 15928715; 61) HNBR5.0-38-80-P-NS-CHG3 (RPN) G13573 (GPN), UDI: (01)00827002135734(17)260311(10)NS15940017 (product), (01)10827002135731(17)260311(30)5(10)NS15940017 (box), Lot Number NS15940017; 62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260220(10)15907354 (product), (01)10827002093123(17)260220(30)5(10)15907354 (box), Lot Number 15907354; 62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260227(10)15919325 (product), (01)10827002093123(17)260227(30)5(10)15919325 (box), Lot Number 15919325; 62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260403(10)15988260 (product), (01)10827002093123(17)260403(30)5(10)15988260 (box), Lot Number 15988260; 62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260411(10)16003544 (product), (01)10827002093123(17)260411(30)5(10)16003544 (box), Lot Number 16003544; 63) HNBR5.0-38-80-P-NS-MPB (RPN) G11469 (GPN), UDI: (01)00827002114692(17)260320(10)15957909 (product), (01)10827002114699(17)260320(30)5(10)15957909 (box), Lot Number 15957909; 64) HNBR5.0-38-80-P-NS-RLG (RPN) G27853 (GPN), UDI: (01)00827002278530(17)260402(10)15985664 (product), (01)10827002278537(17)260402(30)5(10)15985664 (box), Lot Number 15985664; 65) HNBR5.0-38-80-P-NS-VS1 (RPN) G11189 (GPN), UDI: (01)00827002111899(17)260201(10)15879283 (product), (01)10827002111896(17)260201(30)5(10)15879283 (box), Lot Number 15879283; 65) HNBR5.0-38-80-P-NS-VS1 (RPN) G11189 (GPN), UDI: (01)00827002111899(17)260216(10)15901235 (product), (01)10827002111896(17)260216(30)5(10)15901235 (box), Lot Number 15901235; 66) HNBR5.0-38-80-P-NS-VS2 (RPN) G11190 (GPN), UDI: (01)00827002111905(17)260201(10)15879284 (product), (01)10827002111902(17)260201(30)5(10)15879284 (box), Lot Number 15879284; 66) HNBR5.0-38-80-P-NS-VS2 (RPN) G11190 (GPN), UDI: (01)00827002111905(17)260220(10)15907358 (product), (01)10827002111902(17)260220(30)5(10)15907358 (box), Lot Number 15907358.

What the firm is doing

Cook Medical issued an URGENT: MECIAL DEVICE RECALL notice to its consignees on 05/15/2025 via Fed-Ex Standard Overnight mail. The notice explained the reason for the recall, risk to health, and requested the following actions be taken: "Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com." For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. The firm issued an updated notice on 05/22/2025 with the updated UDIs for each product.

DistributionShow details

Worldwide distribution.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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