REINFORCED INTRODUCER SET — Class II medical device recall Z-2224-2023

Ongoing recall by Datascope Corp., reported 2023-08-02, distributed nationwide. During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introdu

Recall number	`Z-2224-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Datascope Corp., Fairfield, NJ, United States
Recall initiated	2023-06-23
Classified	2023-07-21
Reported by FDA	2023-08-02
Distributed	Nationwide (US)
Quantity	321,609 kits
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`10607567106656`, `10607567106694`, `10607567107943`

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2224-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.