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U.S. Department of Health and Human Services

Class 2 Device Recall PiCardia ShortCut

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 Class 2 Device Recall PiCardia ShortCutsee related information
Date Initiated by FirmJuly 06, 2026
Date PostedSeptember 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3213-2026
Recall Event ID 99664
Product Classification Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures - Product Code SCZ
ProductPi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Code Information UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.
FEI Number 3030471525
Recalling Firm/
Manufacturer		 PI CARDIA LTD
5, David Pikes St
Rehovot Israel
For Additional Information ContactHadas Givon
972-8-9484800
Manufacturer Reason
for Recall		Transfemoral catheter, positing arm may detached due to weld issue.
FDA Determined
Cause 2		Process control
ActionOn September 3, 2026 Pi-Cardia issued a Urgent Medical Device Recall Update notification to affected consignees via email. This update provided additional information on the risk to health as well as consignee instructions. Original notification was issued July 9, 2026, Pi Cardia Ltd. informed consignees the following: 1. A member of the Pi-Cardia team will contact you promptly with instructions regarding identification and return of any affected inventory. 2. If you have questions in the meantime, please contact your Pi-Cardia representative. 3. Pi-Cardia will provide additional updates as appropriate.
Quantity in Commerce46 units
DistributionUS Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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