CLASS I ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed
Abiomed is recalling Impella CP Smart Assist Set, JP, Pump Set, distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2690-2026
- FDA event ID
- 98893
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Jun 2026
- FDA classified
- 10 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jun 2026 | Recall initiated by company | |
| 10 Jul 2026 | Classified by FDA | +29 days |
| 22 Jul 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Where it was distributed
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).
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.
Where was it 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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 98893This product is part of a recall event; the main page for the event is Impella CP Set, Pump Set recalled by Abiomed.
More recalls from Abiomed
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Introducer Kit, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Intro Kitand, PKGD, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella 5.5 Smart Assist Set, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella CP Set, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella RP Flex with SmartAssist Set, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |