CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
Sensation. IAB, Intra-Aortic Balloon Catheter recalled by Datascope
Datascope is recalling Sensation. 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-2217-2023
- 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
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0470-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0470-09 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES D684-00-0470-01 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0470-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0469-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES D684-00-0469-01 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY D684-00-0469-09 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs D884-00-0019-16
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Questions about this recall
Is Sensation. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter recalled?
Yes. Datascope recalled Sensation. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter on 23 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2217-2023.
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 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES 10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES 10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY 10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs 10607567106724
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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