Reported Oct 14, 2020 · Terminated

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc. · 22010 SE 51st St · Issaquah, WA · 98029-7298

Is this the product you have?

  • ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Lot codes and dates
  • Model Number10855958
  • GTIN40568690042666
  • Serial Numbers

    333 of 333 codes

    • 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
Amount recalled
N/A

Where it was sold

Why it was recalled

Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 15, 2021 · Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.