FDA Device recall Z-2224-2023
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product De…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product De… 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-2224-2023 |
| 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
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. D684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. D684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. D684-00-0403-10
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 REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr.…Product Description UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. 10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. 10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. 10607567107943 |
|---|
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-2224-2023%22
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