Datascope Corp.: 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.

Agency Publication Date: July 21, 2023

Affected Products

Product: YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-01 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-02 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-01 YAMATO PLUS-R 35cc IAB WITH AC

Product Description UDI YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107585 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107592 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107608 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107615 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107622 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107639

Product: SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDI

Product Description UDI SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES 10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES 10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY 10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs 10607567106724

Product: TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES D684-00-0607 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES D684-00-0608 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs D

Product Description UDI 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES 10607567107656 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES 10607567107663 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 10607567111711 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 10607567111728 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs 10607567107684 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs 10607567111810

Product: MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLO

Product Description UDI MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567107974 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567107981 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109404 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109039 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109046 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111339 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA 10607567111346 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113241 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113258 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10605767109596 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY 10605767109602 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES 10607567107950 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) 10607567107967 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109398 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) 10607567109015 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109022 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111315 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA 10607567111322 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) 10607567113227 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113234 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY 10607567109572 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY 10607567109589 PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs 10607567108025

Product: MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB W

Product Description UDI MEGA 8Fr. 50cc IAB WITH STATLOCK 10607567108001 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA 10607567108018 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109411 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113265 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113272 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109619 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109626 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) 10607567107301 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) 10607567109756 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109763 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB 10607567107493

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

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

Product: SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc

Product Description UDI SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES 10607567108605 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109435 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109381 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113173 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109633 PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB 10607567108599

Product: 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) D684-00-0479-0

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

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 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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92527

Status: Active

Manufacturer: Datascope Corp.

Manufactured In: United States

Units Affected: 9 products (321,609 total kits)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products