FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- Recall number
- Z-2128-2023
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- Status
- Open, Classified
- Initiated
- 2023-05-26
- Posted
- 2023-07-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 37 units
- Distribution
- US Nationwide distribution in the states of MN, NJ, TN.
- Lot, serial or model codes
- UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
- 510(k) numbers
- ["K222113"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28