CLASS I ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
Impella catheters - Intravascular micro axial blood pumps recalled
Abiomed is recalling Impella catheters - Intravascular micro axial blood pumps that support a patient's, distributed nationwide in the US. The recall was initiated on 27 Dec 2023 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-0980-2024
- FDA event ID
- 93749
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Dec 2023
- FDA classified
- 9 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Dec 2023 | Recall initiated by company | |
| 9 Feb 2024 | Classified by FDA | +44 days |
| 21 Feb 2024 | 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
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Product as listed by the FDA
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
Questions about this recall
Why was it recalled?
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Which lots are affected?
UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All product IFUs include the Update ***Added February 2024*** (10) 813502010947 (12) 813502011821 (13) 813502011937 (15) N/A (16) 4260113630242 (17) 813502011777 (18) 813502011265 (19) 4260113630280 (20) 813502011609 (21) 813502012200 (22) 813502011944 (23) 4260113630136 (24) 813502010046 (25) 4260113630174 (26) 813502011197 (27) 813502010053 (28) 813502011630 (29) 813502010466 (30) 813502010473 (31) 813502012453 (32) 813502012767 (33) 813502012873 (34) 813502012873 ***Removed from scope March 15, 2024*** (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (11) 4260113630273 (14) 813502011951
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
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.
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 | Impella CP Smart Assist Set, JP, 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 |
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 |