Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19818 |
| Brand Name: | Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits |
| Model: | IAB-05830-LWS IAB-05830-U IAB-05840-LWS IAB-05840-U IAB-06830-U IAB-06840-U and IAK-06845 (Percutaneous Insertion Kit) |
| Affected: | Multiple |
| Software version: | |
| Recalling Organisation: | InterMed Medical Ltd 71 Apollo Drive Albany AUCKLAND 1311 |
| Contact Information: | 0800 333 444 |
| Manufacturer: | Arrow International Inc |
| Issue: | The Arrow Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits contain a percutaneous sheath introducer. The Percutaneous Sheath Introducer is used by some clinicians in the Intra-Aortic Balloon Catheter insertion procedure. The issue pertains to the sheath introducer in the insertion kit only. The other components of the kits are unaffected. This notice is required following notification by the manufacturer of the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. If bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. In addition, delay of treatment, interruption of treatment, or loss of IAB therapy can occur |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/3/2016 |
