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U.S. Department of Health and Human Services

Class 1 Device Recall 072 Aspiration System

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 Class 1 Device Recall 072 Aspiration Systemsee related information
Date Initiated by FirmFebruary 26, 2025
Date PostedApril 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1512-2025
Recall Event ID 96492
510(K)NumberK222786 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductHippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Code Information REF/UDI-DI/Lot(Expiration): APT6072-132/00857545008127/FG241008C-03(04/07/2025), FG240916C-04(03/17/2025), FG240905C-04(03/06/2025). AP6072-132/00857545008097/FG241206A-03(06/08/2025), FG240917A-01(03/17/2025). APT-95/00857545008103/FG241206A-04(06/08/25)
FEI Number 3020954126
Recalling Firm/
Manufacturer		 Qapel Medical Inc.
4245 Technology Dr
Fremont CA 94538-6339
For Additional Information ContactClaudia Alvarado
510-738-6255
Manufacturer Reason
for Recall		Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
FDA Determined
Cause 2		Device Design
ActionOn 2/26/2025, removal and discontinuation notices were mailed to customers were asked to do the following: 1) Quarantine affected devices and return to the firm. 2) If you have provided this product to others, let the firm know so they can notify them of this action and retrieve any remaining product. 3) Complete and return the Acknowledgement and Response Card via email to orders@qapelmedical.com If you have any questions regarding this letter, please contact customer service for further information at orders@qapelmedical.com, or by phone at 510-738-6255 between the hours of 8am - 5pm PST.
Quantity in Commerce1617
DistributionUS: CA, IL, NE, TN, TX, NJ, NC, SD, FL, MI, PA, GA, AL, IN, NY, WI, AZ, MN, LA, OH, OK, SC, NV, ND, ID, MO, CT, WA, MA. OUS: QATAR, United Arab Emirates, Republic of Kazakhstan
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.
510(K) Database510(K)s with Product Code = NRY
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