| | Class 2 Device Recall LINEAR 7.5Fr.IAB |  |
| Date Initiated by Firm | June 23, 2023 |
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| Date Posted | July 21, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2223-2023 |
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| Recall Event ID |
92527 |
| 510(K)Number | K041281 |
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| 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 |
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| 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
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| FEI Number |
1000222374
|
Recalling Firm/
Manufacturer |
Datascope Corp.
15 Law Dr Unit 1
Fairfield NJ 07004-3206
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| For Additional Information Contact | Datascope/Getinge Customer Service
888-943-8872 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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).
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| Quantity in Commerce | 321,609 total kits |
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| Distribution | Domestic distribution nationwide. International distribution worldwide. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = DSP
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