CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter recalled

Stryker Sustainability Solutions is recalling Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, distributed in 16 states. The recall was initiated on 27 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2197475 2235448 2235454 2243623 2261903 2264435 2264468 2264478 2264484 2039314 2079692 2120924 2121216 2264953 2264955 2264983 2272787 2275104 2073119 2080853 2081724 2081992 2081993 2082097 2611753 2652454 2663966 2663971 2663956 2663959 2663973 2663997 2663999 2664000 2664027 2664028 2664038 2664039 2664041 2664042 2664054 2649640 2649643 2652050 2652100 2652106 2652108 2652123 2652127 2652128 2652130 2652131 2652175 2663895 2663904 2663905 2663907 2663909 2663929 2652008 2652010 2652011 2652080 2652084 2652085 2652090 2652097 2656413 2656414 2656415 2656421 2656442 2656443 2656444 2656448 2656449 2656450 2656458 2656462 2656463 2656474 2656475 2656479 2656485 2656488 2449500 2449504 2449584 2456071 2456077 2456078 2456593 2456604 2456605 2456607 2456609 2456610 2456620 2447265 2459137 2459155

Quantity recalled101 units

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-2113-2020
FDA event ID: 85413
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2020
FDA classified: 22 May 2020
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

27 Mar 2020	Recall initiated by company
22 May 2020	Classified by FDA	+56 days
3 Feb 2021	Published in enforcement report	+257 days

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

Reason for recall

A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

Product as listed by the FDA

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067

Where it was distributed

US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None

Arizona California Florida Georgia Idaho Illinois Indiana Kansas Massachusetts Missouri Pennsylvania Tennessee Texas Virginia Washington West Virginia

Questions about this recall

Is Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter recalled?

Yes. Stryker Sustainability Solutions recalled Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter on 27 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-2113-2020.

Why was it recalled?

Which lots are affected?

2197475 2235448 2235454 2243623 2261903 2264435 2264468 2264478 2264484 2039314 2079692 2120924 2121216 2264953 2264955 2264983 2272787 2275104 2073119 2080853 2081724 2081992 2081993 2082097 2611753 2652454 2663966 2663971 2663956 2663959 2663973 2663997 2663999 2664000 2664027 2664028 2664038 2664039 2664041 2664042 2664054 2649640 2649643 2652050 2652100 2652106 2652108 2652123 2652127 2652128 2652130 2652131 2652175 2663895 2663904 2663905 2663907 2663909 2663929 2652008 2652010 2652011 2652080 2652084 2652085 2652090 2652097 2656413 2656414 2656415 2656421 2656442 2656443 2656444 2656448 2656449 2656450 2656458 2656462 2656463 2656474 2656475 2656479 2656485 2656488 2449500 2449504 2449584 2456071 2456077 2456078 2456593 2456604 2456605 2456607 2456609 2456610 2456620 2447265 2459137 2459155

Where was it sold?

US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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