Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27058 |
| Brand Name: | Penumbra System JET7 and JETD |
| Model: | |
| Affected: | Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (Penumbra reference: 3005168196-12/15/2020-015-R - All lots |
| Software version: | |
| Recalling Organisation: | Penumbra Inc (NZ) C/- NZ Tax Accountants Ltd Suite 817 Level 8 West Plaza Building 3 ALbert Street Auckland 1010 |
| Contact Information: | |
| Manufacturer: | Penumbra Inc |
| Issue: | The manufacturer is recalling the JET 7 Xtra Flex because the catheter may become susceptible todistal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage,and subsequent patient injury or death. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/12/2020 |
