Lower riskMedical device recall · FDA · Published November 8, 2019
Cook CrossCath Support Catheter Recall: Loose or Tight Radiopaque Marker Bands
Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque marker bands that could affect imaging during vascular procedures. Affected units include specific model numbers and lot numbers.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook CrossCath Support Catheter Recall: Loose or Tight Radiopaque Marker Bands.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66544-cook-crosscath-support-catheter-recall-loose-or-tight-radiopaque-marker. Based on FDA recall #Z-0588-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0588-2020%22&limit=1).
The FDA announced on November 8, 2019, that Cook Inc. is recalling CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or tight. The recall affects six units distributed in the U.S. and Brazil.
How to tell if you have it
Brand: Cook
Product: CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0
Order Number: G51575
Lot Number: 9945303
UPC: 00827002515758
The hazard
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters compatible with 0.014 wire guides and too tight on certain CXC3.4 CrossCath Support Catheters compatible with 0.018 wire guides.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls include the Cook Flexor Check-Flo Introducer Ansel Modification recall (November 12, 2021), the Cook Skinny Needle with Chiba Tip Recall (October 13, 2021), and the Cook Transseptal Needle Recall (October 8, 2021). Additional similar product recalls include the Cook Centimeter Sizing Catheters Recall, the Cook Aurous Sizing Catheters Recall, and the Cook Beacon Tip Centimeter Sizing Catheters recall, all dated April 2, 2026.
How to tell if you have this one
Check for the model number RPN CXC3.4-2.2-18-90-P-NS-0 and order number G51575. Lot number 9945303 and UDI (01)00827002515758(17)221308(10)9945303 are also identifiers.
Brand
Cook
Product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.
Recall number
Product, codes & lots
Quantity
Z-0587-2020
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.; Lot Number 9945302 UDI: (01)00827002515727(17)221308(10)9945302 edited to add 2/25/20.
20
Z-0588-2020
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.; Lot Number 9945303 UDI: (01)00827002515758(17)221308(10)9945303
6
Z-0589-2020
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.; Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512
43
Z-0590-2020
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.; Lot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506
58
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number, order number, lot number, and UDI to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed in 20 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Connecticut, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0588-2020 (November 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0588-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.