United StatesABIOMED Impella pump sets and introducer kits are affected, including Impella RP Flex with SmartAssist Set and multiple Impella CP and 5.5 sets and introducer kits, identifiable by the listed pump set codes (for example 1000323, 0048-0003, 1000550) and introducer product codes (for example 2000342, 0052-3046, 0052-3006-JP) and GTINs shown; all current batches in field. They were recalled because a potential for introducer sheath leakage from under the sheath cap and along the hub score lines was identified in 14Fr and 23Fr introducers, which is not visually detectable; 14Fr or 23Fr introducers are provided in every pump set.
What's being recalled
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
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
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
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
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
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
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field. Pump Set Code 0048-0003; Introducer Product Code 0052-3046. GTIN: 00813502012279, 00813502011876. All current batches in field. Pump Set Code 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. All current batches in field. Pump Set Code 1000441; Introducer Product Code 2000342. GTIN: 00813502012910. All current batches in field. Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field. Pump Set Code 0052-0039; Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field. Pump Set Codes 1000211, 1000212; Introducer Product Code 0052-3006-JP. GTIN: 00813502012453. All current batches in field. Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field. Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field. Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field. Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field. Pump Set Code 0052-0011-JP; Introducer Product Code 0052-3006-JP. GTIN: 00813502011340. All current batches in field. Pump Set Code 0052-0023-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011449. All current batches in field.
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)