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
XR000665XR000035XR000405XR000713XR000714XR000717XR000720XR000492XR000493XR000623XR000692XR000693XR000427XR000428XR000429XR000430XR000431XR000432XR000434XR000435XR000437XR000438XR000648XR000656XR000658XR000661XR000568XR000605XR000606XR000607XR000608XR000002XR000596XR000597XR000600XR000601XR000694XR000695XR000587XR000588XR000120XR000131XR000653XR000654XR000698XR000473XR000474XR000475XR000480XR000372XR000373XR000374XR000380XR000011XR000168XR000226XR000227XR000394XR000479XR000517
- 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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