Early Alert: Catheter Introducer Issue from Abiomed and Oscor
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 and its manufacturing partner Oscor have issued a letter to affected customers recommending all Introducer Kits used with Impella heart pumps be corrected prior to continued use.
Affected product contained in Impella Pump sets:
| Introducer Product Code | Introducer Product Description | Pump Set Product Code | GTIN | Pump Set Description |
|---|---|---|---|---|
| 2000342 | Kit, 23Fr Introducer, 11cm, Sterile | 1000323 | 00813502012811 | Impella RP Flex with SmartAssist Set |
| 0052-3021 | Introducer Kit, 23Fr | 0046-0035 | 00813502011869 | Impella RP Set with SmartAssist |
| 0052-3006 | Axillary Insertion Introducer | 1000100 | 00813502012828 | Impella 5.5 Set with SmartAssist |
| 0052-3046 | Kit, 14Fr Introducer, 13cm&25cm, Sterile | 0048-0003 | 00813502012279 00813502011876 | Impella CP Set |
Affected product sold in individual packaging:
| Introducer Product Code | Introducer Product Description | Single Sale Product Code | GTIN | Single Sale Description |
|---|---|---|---|---|
| 2000342 | Kit, 23Fr Introducer, 11cm, Sterile | 1000441 | 00813502012910 | Introducer Kit 23 Fr, 11 cm |
| 0052-3021 | Introducer Kit, 23Fr | 0052-0002 | 00813502011319 | Introducer Kit 23 Fr for Impella RP |
| 0052-3006 | Axillary Insertion Introducer | 0052-0011 | 00813502010015 | Axillary Insertion Kit |
| 0052-3046 | Kit, 14Fr Introducer, 13cm&25cm, Sterile | 1000550 | 00813502013474 | Impella CP Introducer Kit 14 Fr, 13 and 25 cm |
| 0052-3052 | Kit, 14Fr Introducer, 13cm, Long Taper | 0052-0038 | 00813502011708 | Impella CP Introducer Kit 14 Fr, 13 cm |
| 0052-3053 | Kit, 14Fr Introducer, 25cm, Long Taper | 0052-0039 | 00813502011715 | Impella CP Introducer Kit 14 Fr, 25 cm |
What to Do
Hospitals may continue to use existing inventory. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage is observed.
On June 10, 2026, Abiomed and Oscor sent all affected customers a letter recommending the following actions:
- Hospitals may continue to use existing inventory. Physicians should continue to use appropriate clinical awareness, monitoring, and patient support as needed.
- Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed.
- Forward the firm’s notice to anyone in your facility who manages, transports, stores, stocks, or uses the subject products
- If any of the subject products 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 potential for introducer sheath leakage in 14Fr and 23Fr Introducers from the sidearm, under the sheath cap, and along the hub score lines in the hub region. The unexpected leakage in these locations is due to certain manufacturing issues that increase the risk of access-site bleeding.
If this issue were to occur, the user would see blood loss at the sidearm and hub of the introducer sheath as shown below on the 14Fr introducers. Leak locations are the same for both 14Fr and 23Fr introducers.
Introducer leakage may result in access site bleeding at the time of sheath insertion or early device manipulation. This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression, and, in some cases, blood transfusion.
In certain circumstances, particularly patients undergoing large bore vascular access with systemic anticoagulation or limited physiologic reserve (with a bleed that went undetected), exposure to this hazard may result in life-threatening hemorrhage and hemodynamic instability which may lead to death.
As of April 22, Abiomed has reported eight instances of major bleeding and three complaints that have corresponding patient deaths. Abiomed determined that the deaths are not attributable to introducer leakage.
Device Use
The Abiomed Introducer is intended to introduce catheters to the body.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue 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.