Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter
Medical device recall Z-2113-2020. Published in FDA’s Enforcement Report on Feb 3, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 3, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 16 states named in where it went
- 101 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
101 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 807 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None
The states and territories these words name
16 states and territories.
Every one of them
- Arizona
- California
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Massachusetts
- Missouri
- Pennsylvania
- Tennessee
- Texas
- Virginia
- Washington
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 27, 2020.
- FDA classified it on May 22, 2020.
- FDA’s Enforcement Report published it on Feb 3, 2021.
- FDA terminated it on Oct 14, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.