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U.S. Department of Health and Human Services

Class 1 Device Recall Amplatzer" Steerable Delivery Sheath (ASDS)

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 Class 1 Device Recall Amplatzer" Steerable Delivery Sheath (ASDS)see related information
Date Initiated by FirmJune 12, 2023
Date PostedJuly 11, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2110-2023
Recall Event ID 92502
510(K)NumberK220340 
Product Classification Catheter, percutaneous - Product Code DQY
ProductAbbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Code Information UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Recalling Firm/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information ContactCynthia Kong
408-845-0883
Manufacturer Reason
for Recall		There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
FDA Determined
Cause 2		Device Design
ActionAbbott issued a MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023. The notice explained the problem with the device, the risk, and requested the return of all units. Should you have questions about this issue, please contact your local Abbott Representative or Abbott Support at 1-800-544-1664 (Option 2) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.
Quantity in Commerce675 units
DistributionWorldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
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 = DQY
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