| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01042-1 |
| Product Name/Description |
Impella Introducer Kits
Oscor Introducer Kit 14Fr x 13 and 25 cm. REF 0052-3025, as part of
Impella CP SmartAssist Pump Set, REF 0048-0014
Oscor Introducer Kit, 23Fr x 6 cm, REF 0052-3006, as part of
- Impella 5.5 Accessory Kit, REF1000362
- Impella 5.0 Accessory Kit, REF004680-AU-ACC
- Axillary Insertion Kit, REF0052-0011-EU
Introducer Kit, 14Fr x long Pkgd, REF 0052-0017
14 Fr Introducer Kit, REF 0052-0001
Multiple batch and serial numbers.
ARTG's 379190 and 368070 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Through internal investigation during incoming inspections, Abiomed has confirmed <0.6 % occurrence of holes in the outer sterile pouch of the Impella Introducer Kits.
These holes can compromise the sterile barrier.
This type of packaging damage found is isolated to the outer pouches.
Non-sterile introducer kits can expose patients to the possibility of the introduction of micro-organisms into the vasculature, leading to an infectious process, bacteraemia or sepsis. This may result in the need for medical intervention, may potentially lead to permanent injury or impairment or in some cases to life-threatening conditions. |
| Recall Action |
Recall |
| Recall Action Instructions |
User and distributors will be requested to immediately examine their inventory, to quarantine affected product immediately and to not use the suspected product unless no other product is available.
As Abiomed stock inventory of Impella introducers is not sufficient to immediately replace all potentially affected products worldwide, a stepwise replacement will be executed.
Abiomed is actioning the following process for hospitals in Australia:
• The distributor supplies 2 introducers of each affected model to hospitals having no unaffected inventory.
• The distributor holds an expected 4 week inventory of unaffected products to meet hospital reorders.
• The distributor works with the hospitals to exchange affected stock. |
| Contact Information |
+61 424 960 142 - Abiomed Australia Pty Lt. |