CLASS I Device recall · Reported 18 Dec 2019 · FDA Enforcement Report

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-ns recalled by Cook

Cook is recalling CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-ns-0, distributed in 20 states. The recall was initiated on 8 Nov 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506

Quantity recalled58

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0590-2020
FDA event ID: 84212
Recalling firm: Cook, Bloomington, IN
Classification: Class I
Status: Terminated
Recall initiated: 8 Nov 2019
FDA classified: 9 Dec 2019
Reported: 18 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

8 Nov 2019	Recall initiated by company
9 Dec 2019	Classified by FDA	+31 days
18 Dec 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Product as listed by the FDA

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

Where it was distributed

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.

Alabama California Connecticut Florida Georgia Illinois Massachusetts Maryland Michigan Missouri North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Tennessee Texas Virginia

Questions about this recall

Is CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-ns-0 recalled?

Yes. Cook recalled CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-ns-0 on 8 Nov 2019. The recall is Class I and its status is Terminated. Recall number Z-0590-2020.

Why was it recalled?

Which lots are affected?

Lot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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