ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F (Model Number 10855958) due to adverse events involving left atrial perforations and Atrioventricular Node block. The recalled devices were distributed across multiple U.S. states including Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia, as well as in Canada.
The recall affects specific serial numbers beginning with "XR000" that are listed in the recall documentation. The record does not specify what remedy or corrective action consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Reason for recall: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. Distribution: 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 Quantity: N/A Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.