CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular
Abbott Vascular is recalling Product/Part: MitraClip G4 CDS NT Repair-mr Clinical/CDS0704-NT, MitraClip G4 CDS NTW, distributed nationwide in the US. The recall was initiated on 8 Sep 2022 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-0117-2023
- FDA event ID
- 90840
- Recalling firm
- Abbott Vascular, Santa Clara, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2022
- FDA classified
- 20 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Sep 2022 | Recall initiated by company | |
| 20 Oct 2022 | Classified by FDA | +42 days |
| 26 Oct 2022 | 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
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
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
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
Where it was distributed
Worldwide distribution - US Nationwide including in the states of PR, WA, NE, MO, IA, KS, TN, MN, ND, MD, VA, MA, PA, DC, LA, KY, CA, NV, IL, WI, TX, CT, VT, AL, AR, GA, MS, MI, OH, FL, NC, NJ, CO, NY, DE, OR, SC, IN, HI, AZ, NH, ME, WV, OK, ID, UT, MT, NM, RI, AK, SD and the countries of AE, AR, AT, AU, BE, BG, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LU, MT, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Which lots are affected?
Part/UDI-GTIN: CDS0704-NT/08717648234576, CDS0704-NTW/08717648234590, CDS0704-XT/08717648234583, CDS0704-XTW/08717648234606, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961, TCDS0303-NT/08717648334276, TCDS0303-NTW/08717648334290, TCDS0303-XT/08717648334283, TCDS0303-XTW/08717648334306, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961 All lots.
Where was it sold?
Worldwide distribution - US Nationwide including in the states of PR, WA, NE, MO, IA, KS, TN, MN, ND, MD, VA, MA, PA, DC, LA, KY, CA, NV, IL, WI, TX, CT, VT, AL, AR, GA, MS, MI, OH, FL, NC, NJ, CO, NY, DE, OR, SC, IN, HI, AZ, NH, ME, WV, OK, ID, UT, MT, NM, RI, AK, SD and the countries of AE, AR, AT, AU, BE, BG, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LU, MT, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW.
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
2 other products · FDA event 90840This product is part of a recall event; the main page for the event is Product/Part: MitraClip XTR Clip Delivery System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Product/Part: MitraClip XTR Clip Delivery System recalled | Abbott Vascular | Device Malfunction | Nationwide | |
| CLASS II | Product/Part: MitraClip NTR Clip Delivery System recalled | Abbott Vascular | Device Malfunction | Nationwide |
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 Indeflator, REF: 1000184, for use during cardiovascular recalled | 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 NTR Clip Delivery System recalled | Abbott Vascular | Device Malfunction | Nationwide |
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