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U.S. Department of Health and Human Services

Class 2 Device Recall MEGA 8Fr. IAB

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  Class 2 Device Recall MEGA 8Fr. IAB see related information
Date Initiated by Firm June 23, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2220-2023
Recall Event ID 92527
510(K)Number K133074  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
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 WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10
MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U
MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U
MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01
MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07
MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08
PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17
Code Information 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
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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