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U.S. Department of Health and Human Services

Class 2 Device Recall LINEAR 7.5Fr.IAB

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  Class 2 Device Recall LINEAR 7.5Fr.IAB see related information
Date Initiated by Firm June 23, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2223-2023
Recall Event ID 92527
510(K)Number K041281  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
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) D684-00-0479-02C
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 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
Recalling Firm/
Manufacturer		 Datascope Corp.
15 Law Dr Unit 1
Fairfield NJ 07004-3206
For Additional Information Contact Datascope/Getinge Customer Service
888-943-8872
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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