Source: US Department of Health and Human Services – 3
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.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.
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
0081350201227900813502011876
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 Kit23 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 IntroducerKit 14 Fr, 13 and 25 cm
0052-3052
Kit, 14Fr Introducer, 13cm, Long Taper
0052-0038
00813502011708
Impella CP IntroducerKit 14 Fr, 13 cm
0052-3053
Kit, 14Fr Introducer, 25cm, Long Taper
0052-0039
00813502011715
Impella CP IntroducerKit 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 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.