Skip to content

Impella Heart Pump recallZ-2128-2023 · Abiomed, Inc. · initiated May 26, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2128-2023
Status
Open, Classified
Initiated by the company
May 26, 2023
Posted by the FDA
Jul 11, 2023
Recalling firm
Abiomed, Inc.
Quantity
37 units
Product code
DYB
FDA submissions
K222113
Distribution
US Nationwide distribution in the states of MN, NJ, TN.

Product description

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Code information (models, lots, serial numbers)

UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K222113 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page