Z-2224-2023Class II

REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation...

Name: Z-2224-2023 REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation...
Creator: Datascope Corp.
Published: 2023-06-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-06-23 / Open, Classified

FDA source

Datascope Corp. began a recall of REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part... on 2023-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2224-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-23
Posted: 2023-07-21
Recalling firm: Datascope Corp.
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
Product code: DYB Introducer, Catheter
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.
FDA root cause: Under Investigation by firm
Action: Firm notified customers on June 23, 2023 via letter. Customers were made aware of the potential for the device to break during use and the risk of using the device. Customers were given alternate solutions to continue using the IAB Catheter with alternative sheath/dilator combinations. Customers may also return their affected product for a credit. The firm will continue to ship product to customers who choose to continue receiving it. However, product currently being shipped is potentially affected by the same issue. Datascope/Getinge has identified the issue with the introducer dilator and is working with the supplier towards a resolution. If you have any questions, please contact your Datascope/Getinge representative or call Datascope/Getinge Customer Service at 1-888-943-8872, options 2, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 321,609 total kits
Distribution: Domestic distribution nationwide. International distribution worldwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2224-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2216-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2217-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2218-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2219-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2220-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2221-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2222-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2223-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21
Z-2224-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code DYB

K002365Class IIDatascope Reinforced Percutaneous Catheter Introducer SetDatascope Corp. / cleared 2000-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)