ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Medical device recall Z-0090-2021. Published in FDA’s Enforcement Report on Oct 14, 2020.
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 Oct 14, 2020. Copied from openFDA on Oct 20, 2026.
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?
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 10855958 GTIN: 40568690042666 Serial Numbers: XR000665 XR000035 XR000405 XR000713 XR000714 XR000717 XR000720 XR000492 XR000493 XR000623 XR000692 XR000693 XR000427 XR000428 XR000429 XR000430 XR000431 XR000432 XR000434 XR000435…
Every code shown here, 1,995 characters
Model Number: 10855958 GTIN: 40568690042666 Serial Numbers: XR000665 XR000035 XR000405 XR000713 XR000714 XR000717 XR000720 XR000492 XR000493 XR000623 XR000692 XR000693 XR000427 XR000428 XR000429 XR000430 XR000431 XR000432 XR000434 XR000435 XR000437 XR000438 XR000648 XR000656 XR000658 XR000661 XR000568 XR000605 XR000606 XR000607 XR000608 XR000002 XR000596 XR000597 XR000600 XR000601 XR000694 XR000695 XR000587 XR000588 XR000120 XR000131 XR000653 XR000654 XR000698 XR000473 XR000474 XR000475 XR000480 XR000372 XR000373 XR000374 XR000380 XR000011 XR000168 XR000226 XR000227 XR000394 XR000479 XR000517 XR000518 XR000598 XR000602 XR000603 XR000007 XR000008 XR000012 XR000013 XR000018 XR000019 XR000022 XR000023 XR000028 XR000260 XR000265 XR000756 XR000759 XR000029 XR000609 XR000610 XR000486 XR000487 XR000488 XR000489 XR000213 XR000214 XR000216 XR000218 XR000220 XR000221 XR000222 XR000223 XR000224 XR000225 XR000420 XR000421 XR000424 XR000425 XR000442 XR000443 XR000444 XR000445 XR000446 XR000447 XR000448 XR000449 XR000450 XR000451 XR000452 XR000453 XR000454 XR000455 XR000456 XR000457 XR000458 XR000459 XR000460 XR000461 XR000462 XR000463 XR000464 XR000465 XR000466 XR000467 XR000494 XR000495 XR000496 XR000497 XR000500 XR000502 XR000503 XR000504 XR000505 XR000506 XR000507 XR000509 XR000510 XR000511 XR000512 XR000513 XR000514 XR000544 XR000548 XR000551 XR000555 XR000556 XR000559 XR000560 XR000662 XR000666 XR000741 XR000746 XR000747 XR000748 XR000696 XR000697 XR000707 XR000711 XR000490 XR000491 XR000524 XR000525 XR000527 XR000530 XR000369 XR000381 XR000390 XR000769 XR000770 XR000705 XR000709 XR000710 XR000379 XR000385 XR000126 XR000132 XR000133 XR000134 XR000140 XR000141 XR000142 XR000144 XR000422 XR000423 XR000440 XR000441 XR000468 XR000469 XR000470 XR000471 XR000472 XR000477 XR000478 XR000498 XR000499 XR000515 XR000523 XR000526 XR000575 XR000576 XR000593 XR000595 XR000621 XR000622 XR000641 XR000642 XR000663 XR000669 XR000718 XR000719 XR000128 XR000130 XR000148 XR000519 XR000520…
FDA’s list runs to 3,056 characters. The first part is shown; the rest is on FDA’s record.
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.
U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada
The states and territories these words name
19 states and territories.
Every one of them
- Arizona
- California
- Florida
- Georgia
- Illinois
- Kentucky
- Massachusetts
- Michigan
- Minnesota
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- 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 May 22, 2020.
- FDA classified it on Oct 8, 2020.
- FDA’s Enforcement Report published it on Oct 14, 2020.
- FDA terminated it on Oct 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Issaquah, WA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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.”
- FDA’s list of codes runs to 3,056 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.