CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Introducer Kit, w/Hlx Vlv Sterile Individual recalled by Abiomed
Abiomed is recalling Introducer Kit, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, distributed nationwide in the US. The recall was initiated on 7 Nov 2023 and the FDA has classified it as Class II.
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-0649-2024
- FDA event ID
- 93501
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Nov 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Nov 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +59 days |
| 17 Jan 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
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
Where it was distributed
Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
Questions about this recall
Why was it recalled?
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.
Which lots are affected?
UDI-DI: 00885672009786
Where was it sold?
Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
9 other products · FDA event 93501This product is part of a recall event; the main page for the event is Kit Introducer&, Sterile Part of Pump Set (0048 recalled by Abiomed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Kit Introducer&, Sterile Part of Pump Set (0048 recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Oscor Intro Kitand Part of Pump Set recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Axillary Insertion Introducer -Introducer(s) are intended recalled | Abiomed | Sterility | Nationwide | |
| CLASS II | Kit Introducer, Long Taper Individual recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Oscor Introducer Kit x Long Individual recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Kit Introducer, Long Taper Individual recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Oscor Introducer Kit x Short Individual recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | Kit Introducer, Sterile Part of Pump Set recalled by Abiomed | Abiomed | Sterility | Nationwide | |
| CLASS II | KIT Introducer, 13 &, ABMD Part of Pump Set (0048 recalled by Abiomed | Abiomed | Sterility | Nationwide |
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 |