CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
MEGA 7..IAB , Intra-Aortic Balloon Catheter and Accessories recalled
Datascope is recalling MEGA 7..IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter, distributed nationwide in the US. The recall was initiated on 23 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2219-2023
- FDA event ID
- 92527
- Recalling firm
- Datascope, Fairfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2023
- FDA classified
- 21 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 23 Jun 2023 | Recall initiated by company | |
| 21 Jul 2023 | Classified by FDA | +28 days |
| 2 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Domestic distribution nationwide. International distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 92527This product is part of a recall event; the main page for the event is Linear 7..IAB, Intra-Aortic Balloon Catheter recalled by Datascope.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Linear 7..IAB, Intra-Aortic Balloon Catheter recalled by Datascope | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Sensation. IAB, Intra-Aortic Balloon Catheter recalled by Datascope | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Yamato Plus Iab recalled by Datascope | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Sensation Plus recalled by Datascope | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Trans-ray IAB, Intra-Aortic Balloon Catheter recalled by Datascope | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Reinforced Introducer Set, Intra-Aortic Balloon Catheter recalled | Datascope | Other | Nationwide | |
| CLASS II | MEGA. IAB, Intra-Aortic Balloon Catheter and Accessories recalled | Datascope | Packaging Defects | Nationwide | |
| CLASS II | Sensation Plus recalled by Datascope | Datascope | Packaging Defects | Nationwide |
More recalls from Datascope
All 134| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Battery Charging Station recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS II | CS100 IABP recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS II | CS300 IABP recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS III | Cardiosave Hybrid recalled by Datascope | Datascope | Other | Nationwide |
| Device | CLASS III | Cardiosave Rescue recalled by Datascope | Datascope | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |