Recall Z-0090-2021
Siemens Medical Solutions USA, Inc. · initiated May 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Codes / lots: 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…
Reason for recall
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
FDA-determined cause: Under Investigation by firm
Action taken
On 05/22/2020, the firm notified customers via telephone of the recall and send on 05/26/2020 an email with an attached "URGENT SAFETY ADVISORY NOTIFICATION" Letter inform customer that the Recalling Firm has received reports of left atrial perforations and Atrioventricular Node block occurring while using the affected product. The customer notification instructs customers to: -Immediately stop performing procedures using the affected catheters and segregate the product. -All remaining affected inventory in their possession will be collected. The following steps outline the sequence of this process: -Users of the device have been contacted personally by the Recalling Firm's Ultrasound Management; -Customers will be reimbursed for their remaining, unused inventory; -A Clinical Specialist will call to schedule a time to document and retrieve inventory. OR Customers may ship the remaining inventory to the following address. Customers that wish to ship remaining inventory, should inform the Clinical Specialist of this when they are contacted. Address to return products: Siemens Healthineers Ultrasound Attention: Kristen Clyman 22010 S.E. 51st Street Issaquah, WA 98029 Customer are also instructed to: -Complete the Recall Acknowledgement Form and return to the Recalling Firm as soon as possible and email to Kristen.Clyman@siemens-healthineers.com, and -Ensure that all users of the affected products within your organization and others who may need to be informed receive the safety relevant information provided with the notice and take the actions specified therein.
Details
- Recall number
- Z-0090-2021
- Initiated
- May 22, 2020
- Terminated
- October 15, 2021
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- 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
- Recalling firm
- Siemens Medical Solutions USA, Inc., Issaquah, WA