CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
20/30 Indeflator, REF: 1000184, for use during cardiovascular recalled
Abbott Vascular is recalling 20/30 Indeflator, REF: 1000184, for use during cardiovascular, distributed in 40 states. The recall was initiated on 6 Nov 2024 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-0730-2025
- FDA event ID
- 95707
- Recalling firm
- Abbott Vascular, Temecula, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 6 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +44 days |
| 1 Jan 2025 | 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
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
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
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Where it was distributed
US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Which lots are affected?
UDI-DI: 08717648013591, Lots: 60418466, 60418467, 60418468
Where was it sold?
US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
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
3 other products · FDA event 95707This product is part of a recall event; the main page for the event is 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states | |
| CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states | |
| CLASS II | 20/30 Priority Pack Kit/.115 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
More recalls from Abbott Vascular
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 20/30 Priority Pack Kit/.115 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular | Abbott Vascular | Device Malfunction | Nationwide |
| Device | CLASS II | Product/Part: MitraClip NTR Clip Delivery System recalled | Abbott Vascular | Device Malfunction | 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 |