LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and… recallZ-2223-2023 · Datascope Corp. · initiated Jun 23, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-2223-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 23, 2023
- Posted by the FDA
- Jul 21, 2023
- Recalling firm
- Datascope Corp.
- Quantity
- 321,609 total kits
- Product code
- DSP
- FDA submissions
- K041281
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
Product description
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0479-01C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0479-02C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0479-07 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0479-08 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) D684-00-0479-09 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0479-10 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0479-01U LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0479-02U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0480-01 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0480-02 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0480-01C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0480-02C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0480-07 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) D684-00-0480-08 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0480-09 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0480-10 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0480-01U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0480-02U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES D684-00-0478-01 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) D684-00-0478-02 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) D684-00-0478-01C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) D684-00-0478-02C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) D684-00-0478-07 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0478-08 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) D684-00-0478-09 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0478-10 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY D684-00-0478-01U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY D684-00-0478-02U PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs D884-00-0019-12 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs D884-00-0019-13
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Product Description UDI LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES 10605767106557 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) 10605767106540 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10605767109329 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) 10605767109336 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10605767109695 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) 10605767109701 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) 10605767113180 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10605767113142 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10605767109503 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY 10605767109510 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567106564 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567106571 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109343 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) 10607567109350 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109718 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) 10607567109725 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113197 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113159 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109527 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109534 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES 10607567106526 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) 10607567106533 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) 10607567109305 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) 10607567109312 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) 10607567109671 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109688 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) 10607567113203 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113210 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY 10607567109480 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY 10607567109497 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs 10607567106632 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs 10607567106649
Devices named in this recall
22 devices in the FDA device registry whose identifier appears in the recall's code information.
- Linear 7.5Fr. 40cc IAB 0684-00-0480-01Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall4 deaths168 reports
- Linear 7.5Fr. 40cc IAB (with APA) 0684-00-0480-02Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls1 death26 reports
- Linear 7.5Fr. 40cc IAB (INDIA) 0684-00-0480-07Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall2 deaths63 reports
- Linear 7.5Fr. 40cc IAB (China) 0684-00-0480-01CDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 death32 reports
- Linear 7.5Fr. 25cc IAB 0684-00-0478-01Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall8 reports
- Linear 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0480-01UDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 death6 reports
- Linear 7.5Fr. 25cc IAB with Accessories, US Only 0684-00-0478-01UDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall4 reports
- Linear 7.5Fr. 40cc IAB (INDIA) (with APA) 0684-00-0480-08Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall2 reports
- Linear 7.5Fr 40cc IAB with Accessories (APA) (Turkey) 0684-00-0480-10Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall2 reports
- Linear 7.5Fr. 25cc IAB (with APA) 0684-00-0478-02Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 report
- Linear 7.5Fr. 40cc IAB with Accessories (APA), US Only 0684-00-0480-02UDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 report
- Linear 7.5Fr 25cc IAB with Accessories (APA) (Turkey) 0684-00-0478-10Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 report
- Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB 0884-00-0019-12Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I 0884-00-0019-13Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 25cc IAB (China) 0684-00-0478-01CDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 25cc IAB (with APA) (China) 0684-00-0478-02CDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 40cc IAB (with APA) (China) 0684-00-0480-02CDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 25cc IAB (with APA) US Only 0684-00-0478-02UDatascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 25cc IAB (INDIA) 0684-00-0478-07Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr. 25cc IAB (INDIA)(with APA) 0684-00-0478-08Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr 40cc IAB with Accessories (Turkey) 0684-00-0480-09Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- Linear 7.5Fr 25cc IAB with Accessories (Turkey) 0684-00-0478-09Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92527).
- Z-2216-2023 · Open, ClassifiedYAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description …
- Z-2217-2023 · Open, ClassifiedSENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2218-2023 · Open, ClassifiedTRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2219-2023 · Open, ClassifiedMEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2220-2023 · Open, ClassifiedMEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2221-2023 · Open, ClassifiedSENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2222-2023 · Open, ClassifiedSENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
- Z-2224-2023 · Open, ClassifiedREINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page