Early Alert: Catheter Introducer Kit Issue from Abiomed
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Abiomed has issued a letter to affected customers recommending all 14Fr Low Profile Introducer Kits be removed from where they are used or sold.
Affected devices:
Product Code | Product Description | UDI-DI |
|---|---|---|
1000434 | 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP | |
1000435 | 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP | |
1000413 | Impella CP Set with SmartAssist (10th Generation) |
What to Do
Do not use affected product. Review your inventory for the affected Introducer Kits and quarantine any identified products for return.
On May 22, Abiomed sent all affected customers a letter recommending the following actions:
- Review your inventory for the affected Introducer Kits and quarantine any identified product
- Return the affected product to Sedgwick
- Notify anyone in your facility who manages, transports, stores, stocks, or uses these devices
- If any 14Fr Low Profile Introducer Kits have been forwarded to another facility, contact that facility and provide them with the firm’s notice
- Post a copy of the firm’s notice in a visible area for awareness
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Abiomed has identified a higher rate of complaints than expected related to thrombus formation on the 14Fr Low Profile Introducer Kit during prolonged use of the introducer. If thrombus formation occurs, the user may have difficulty aspirating the sheath sidearm or valve. The user may also observe thrombus in the syringe or sidearm post aspiration or around the valve following CP pump removal.
Thrombus formation within the indwelling sheath lumen or the annular gap between the sheath inner diameter and the catheter outer diameter during prolonged support may result in disruption of blood flow near the access site. If thrombus is dislodged during ongoing support, manipulation, or removal, this may result in peripheral vessel obstruction with ischemia requiring prompt clinical assessment and intervention to restore perfusion. Under less common circumstances, exposure could progress to irreversible vascular occlusion with potential for permanent impairment if not corrected.
The 14Fr Low Profile Introducer Kit (Product codes 1000434 & 1000435) is only compatible with Impella CP 10th generation (Product code 1000413) and therefore the pump set is included in the removal. This recall does not involve any other generation of Impella CP that is commercially available.
As of May 15, Abiomed has reported three serious injuries and no deaths associated with this issue.
Device Use
The 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP with SmartAssist and ancillary devices.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed at OneMD-Field-Actions@its.jnj.com.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.