A medical device recall is issued when the FDA determines that a device violates FDA law because it is defective, poses a risk to patient health, or both. Recalls are meant to protect patients by ensuring unsafe or non‑compliant devices are identified and addressed quickly.
Class I Recall is a situation where there is a reasonable chance that a product will cause serious health problems or death.
What Is the Cook Medical Sizing Catheter Recall About?
Cook Medical determined that marker bands on certain sizing catheters may be at increased risk of cracking or breaking during use. These marker bands help physicians orient the catheter during angiographic procedures. When they fail, the consequences can be serious.
Potential complications include:
- Longer procedure times
- Device fragmentation or separation inside the body
- Vessel injury or trauma
- In the most severe cases, life‑threatening harm or death
As of April 2, no deaths or serious injuries have been reported. However, the risk was significant enough for the FDA to issue a Class I recall, the most serious type of recall.
On that date, Cook Medical sent out a letter to tell affected customers to examine their inventory to determine if they had affected products and quarantine any affected products that were not already used. The company had found that the marker bands on specific catheters could be at an increased risk of breaking or cracking.
Also, in April, the FDA published an early alert that the catheters in question were linked to an increased risk of cracking or breaking while being used.
Which Sizing Catheters Are Included in the Recall?
The recall applies to specific lots of the following Cook Medical products:
- Centimeter Sizing Catheters
- Aurous Centimeter Sizing Catheters
- Beacon Tip Centimeter Sizing Catheters
These devices are commonly used in angiographic procedures and come in various lengths (70 cm and 100 cm) and tip configurations (straight, PIG, and VCF).
To determine whether your catheter is included, review the full list of recalled lots: View affected lots
Why A Recall Matters
When a product malfunctions due to a design defect, it can cause serious harm. Should the Cook sizing catheter crack, break, or fragment during a procedure, patients may require:
- Additional imaging
- Emergency retrieval procedures
- Extended hospitalization
- Treatment for vessel damage
- Long‑term monitoring for complications
What Healthcare Facilities Need to Know
Cook Medical instructed all customers to:
- Stop using recalled sizing catheters immediately
- Quarantine and return all unused affected products to Cook Medical
- Cease distribution of any remaining inventory
- Notify all relevant staff and organizations that may have received the device
- Report any adverse events
Adverse events may be reported to Cook Medical Customer Relations at 800‑457‑4500 or 812‑339‑2235 (Monday–Friday, 7:30 am–5:00 pm ET) or by email at [email protected].
Facilities were also advised to report adverse events to the FDA’s MedWatch program: Report to MedWatch
Do You Have a Potential Sizing Catheter Claim?
If you believe a recalled Cook Medical sizing catheter caused you injury, speaking with an experienced product liability attorney is the best way to protect your rights.
The Nash & Franciskato Law Firm has extensive experience representing individuals harmed by defective medical devices. Our team has secured significant results against major manufacturers and understands the complexities of medical device litigation.
Medical device manufacturers have a responsibility to ensure their products are safe. When they fail, patients pay the price—and legal action may be the only way to hold them accountable.
Call (877) 284‑6600 or start your free, no-obligation case review below.
Resources: US Food and Drug Administration
- Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters –
- What is a Medical Device Recall?
Originally Published: May 27, 2026
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