CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report
The Acist Angiographic Injection System is intended to be recalled
Acist Medical Systems is recalling Acist Medical Systems Inc. The Acist Angiographic Injection System is intended to be used, distributed nationwide in the US. The recall was initiated on 15 Mar 2013 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-1145-2013
- FDA event ID
- 64840
- Recalling firm
- Acist Medical Systems, Eden Prairie, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2013
- FDA classified
- 18 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2013 | Recall initiated by company | |
| 18 Apr 2013 | Classified by FDA | +34 days |
| 24 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Where it was distributed
Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyMarylandMichiganMinnesotaMissouri
Questions about this recall
Is The Acist Angiographic Injection System is intended to be used for the controlled recalled?
Yes. Acist Medical Systems recalled The Acist Angiographic Injection System is intended to be used for the controlled on 15 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1145-2013.
Why was it recalled?
ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
Which lots are affected?
23884007, 23884008, 23884009
Where was it sold?
Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
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.
More recalls from Acist Medical Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Acist Kodama Intravascular Ultrasound Catheter The Kodama recalled | Acist Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | BT2000 Automated Manifold Kit recalled by Acist Medical Systems | Acist Medical Systems | Sterility | Nationwide |
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