A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Use this page to screen for a possible match. Use the linked official notice before you stop use, throw away, return, repair or schedule service.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Check device name, UDI, model, lot, serial and software version.
Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.
Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.
Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.
Device recalls can depend on UDI, model, catalog number, lot, serial number, software version or implant card details. Match the label before changing device use.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Use the official notice for remedy instructions. Product recall remedies may include repair, replacement, refund, disposal, software update, dealer service or a stop-use instruction.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.
Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.
Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.
Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.
Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.
Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.
Recall remedies differ by agency and product type. The official notice is the final source for repair, refund, replacement, disposal, dealer service or stop-use steps.
This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.
| Product Recall | Source | Type | Risk | Date | Action |
|---|---|---|---|---|---|
|
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
|
FDA
Z-2684-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 11, 2026
|
Details |
|
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
|
FDA
Z-2709-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 1, 2026
|
Details |
|
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
|
FDA
Z-2690-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 11, 2026
|
Details |
|
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
|
FDA
Z-2693-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 11, 2026
|
Details |
|
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
|
FDA
Z-2687-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 11, 2026
|
Details |
|
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
|
FDA
Z-2680-2026
|
Medical Device | High |
Jul 22, 2026
Recall: Jun 10, 2026
|
Details |
Compare the product name, brand, model, UPC, lot code, serial number, VIN, date code, package size, retailer and distribution details with the official notice. All key details should match.
Stop using, feeding, driving or consuming the product when the notice says to do so, then follow the official remedy for repair, replacement, refund, disposal, service or company contact.
No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.
Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.