FDA Device recall Z-2222-2023
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Desc…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Desc… by Datascope, citing during IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2222-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-23 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0576-09 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0576-01U PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB D884-00-0019-23
Reason
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Identifiers
| code_info | Product Description UDI SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIE…Product Description UDI SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES 10607567108605 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109435 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109381 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113173 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109633 PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB 10607567108599 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2222-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.