ModerateClass IIOngoing

FDA Devices recall · Reported October 26, 2022

Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0116-2023.

Q: Where was the recalled product distributed?

Distribution: 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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0116-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 p…

Recall #: Z-0116-2023
Affected scope: 20,045
Initiated: September 8, 2022

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

View my saved recalls

Abbott Vascular recalled Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Deli… - a moderate-severity action.

Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Deli… was recalled by Abbott Vascular in October 26, 2022. Reason: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been …. Check the official notice for the remedy. Verify recall #Z-0116-2023 with the FDA Devices before acting.

Share: Post Facebook LinkedIn WhatsApp Email

The recall

Abbott Vascular issued this moderate-severity FDA Devices recall — An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been ….

Moderate
severity level: 20K units
affected scope: Class II
classification: October 26, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0116-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0116-2023) was formally reported on October 26, 2022, with the manufacturer initiating the action on September 8, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Vascular is listed as the recalling firm, operating out of Santa Clara, CA. Federal records list the affected scope as 20,045.

The documented reason for this recall is: 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. Un… Distribution data in the federal record shows the product reached: 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, H…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

20,045

Related Recalls

6 from same agency

Product description

Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT, MitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW, TriClip XT Clip Delivery Sys CE/TCDS0202-XT, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip XT Clip Delivery Sys ROW/TCDS0205-XT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT, TriClip G4 NT Delivery System CE/TCDS0302-NT, TriClip G4 NTW Delivery System CE/TCDS0302-NTW, TriClip G4 XT Delivery System CE/TCDS0302-XT, TriClip G4 XTW Delivery System CE/TCDS0302-XTW, TriClip G4 NT Delivery System ROW/TCDS0305-NT, TriClip G4 NTW Delivery System ROW/TCDS0305-NTW, TriClip G4 XT Delivery System ROW/TCDS0305-XT, TriClip G4 XTW Delivery System ROW/TCDS0305-XTW, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0116-2023
Date reported	October 26, 2022
Date initiated	September 8, 2022
Recalling firm	Abbott Vascular
Firm location	Santa Clara, CA
Affected scope	20,045
Distribution	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, O…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

20,045 units affected — limited or regional distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0116-2023) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting — recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0116-2023.

Where was the recalled product distributed? ▼

Distribution: 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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0116-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Continue exploring

Keep tracking product safety across the federal recall archive.

Recall Checker

Search the full archive by product name, brand, or recall number across every agency.

Check a product →

FDA Devices recalls

Every recall issued by FDA Devices, newest first.

Browse the feed →

RecallRadar

Live feed of the latest recalls across the FDA, CPSC and NHTSA — filter by agency and severity.

View the live feed →

Rankings

The largest recalls by units affected and the most-recalled product categories.

See the rankings →

Browse by category

Find recalls by product type to spot recurring defect patterns.

All categories →

What to do next

A step-by-step guide to refunds, repairs, and returns after a recall.

Read the guide →

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

FDA Devices Moderate

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…

GE Medical Systems Information Technologies Inc · 2026-06-03

FDA Devices Critical

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…

Medline Industries, LP · 2026-06-03

FDA Devices Critical

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Med…

Medline Industries, LP · 2026-06-03

FDA Devices Critical

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella C…

Abiomed, Inc. · 2026-06-03

FDA Devices Moderate

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCA…

GE Medical Systems Information Technologies Inc · 2026-06-03

Compare this recall with GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L… →

Browse all Medical Devices recalls →

Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 26, 2022.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.