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U.S. Department of Health and Human Services

Class 2 Device Recall Abiomed 14Fr Low Profile Introducer Set

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  Class 2 Device Recall Abiomed 14Fr Low Profile Introducer Set see related information
Date Initiated by Firm May 26, 2023
Date Posted July 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2128-2023
Recall Event ID 92521
510(K)Number K222113  
Product Classification Introducer, catheter - Product Code DYB
Product Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Code Information UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
Recalling Firm/
Manufacturer		 Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact Shashi Thoutam)
734-262-6255
Manufacturer Reason
for Recall		 There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
FDA Determined
Cause 2		 Under Investigation by firm
Action An URGENT: VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) notification letter was delivered to customers on 5/23/23. Customers were also contacted via telephone on 5/26/23. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your Abiomed local clinical field staff to coordinate the return of the subject products. 3. Review, complete all fields, sign, and return the attached Business Response Form (BRF) on the last page of this letter to the Recall Coordinator identified in this document. 4. Forward this notice to any personnel in your facility who needs to be informed. 5. If any of the product subject to this recall (removal) has been forwarded to another facility, contact that facility immediately and provide a copy of this notice to the relevant personnel. 6. Post a copy of this field safety notice in a visible area for awareness. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reportingprogram/reporting-serious-problems-fda If you have questions or concerns regarding this notice, please contact (Shashi Thoutam) directly at +1(734) 262-6255 and/or your local clinical field staff.
Quantity in Commerce 37 units
Distribution US Nationwide distribution in the states of MN, NJ, TN.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DYB and Original Applicant = Abiomed Inc.
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