Question 1

What product was recalled?

Accepted Answer

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 STATLOCK)	                      D684-00-0295-03  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)	                                   D684-00-0295-05  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA)	                D684-00-0295-06  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA	          D684-00-0295-07  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA  D684-00-0295-08  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)	                                   D684-00-0295-09  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY)	                      D684-00-0295-10  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY	                                   D684-00-0295-01U  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY	                             D684-00-0295-02U  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES	                                                      D684-00-0294-01  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA)	                                         D684-00-0294-02  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK)	                      D684-00-0294-03  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA)	                                   D684-00-0294-05  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA)	                D684-00-0294-06  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA	          D684-00-0294-07  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA)   INDIA  D684-00-0294-08  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY)	                                   D684-00-0294-09  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY)	                       D684-00-0294-10  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY	                                   D684-00-0294-01U  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY	                             D684-00-0294-02U  PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs                               D884-00-0019-21. Recalled by Datascope Corp.. Units affected: 321,609 total kits.

Question 2

Why was this product recalled?

Accepted Answer

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.

Question 3

Which agency issued this recall?

Accepted Answer

This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2219-2023.

Product Description

Reason for Recall

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