FDA Device recall Z-2221-2023
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Des…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Des… 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-2221-2023 |
| 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 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE D684-00-0568-05 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) D684-00-0568-09 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY D684-00-0568-01U PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB D884-00-0019-22
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 7.5Fr. 40cc WITH ACCESSORIES…Product Description UDI SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES 10607567108063 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) 10607567109428 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE 10607567109442 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) 10607567113166 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY 10607567109565 PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB 10607567108612 |
|---|
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-2221-2023%22
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