MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in…
Medical device recall Z-2219-2023. Published in FDA’s Enforcement Report on Aug 2, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 2, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 321,609 total kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
321,609 total kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,532 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. International distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 23, 2023.
- FDA classified it on Jul 21, 2023.
- FDA’s Enforcement Report published it on Aug 2, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datascope Corp., of Fairfield, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.