PlainRecalls

Abbott Vascular

Compiled from official public sources by the editorial team.

37 recalls on record · Latest: Oct 26, 2022

Abbott Vascular Recall Insight

Abbott Vascular appears on 37 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.036% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 26, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 37 entries, severity tagging shows 23 critical, 14 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 37 of 37 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (37). The date window on this page runs from Oct 3, 2012 to Oct 26, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 26, 2022

Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery Sys…

FDA Devices Moderate Oct 26, 2022

Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery Sys…

FDA Devices Moderate Oct 26, 2022

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…

FDA Devices Critical May 25, 2022

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

FDA Devices Moderate Apr 20, 2022

Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-…

FDA Devices Moderate Apr 20, 2022

INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

FDA Devices Moderate Apr 20, 2022

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

FDA Devices Moderate Apr 20, 2022

20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-0…

FDA Devices Moderate Apr 20, 2022

20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

FDA Devices Moderate Jun 24, 2020

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224…

FDA Devices Critical Feb 26, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is no…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated f…

FDA Devices Critical Feb 26, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not…

FDA Devices Critical Feb 26, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is no…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …

FDA Devices Critical Feb 26, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …

FDA Devices Critical Feb 26, 2020

NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…

FDA Devices Moderate Jun 5, 2019

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

FDA Devices Moderate Mar 6, 2019

PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or …

FDA Devices Critical Jun 7, 2017

Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal dia…

FDA Devices Critical May 24, 2017

NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 101…

FDA Devices Critical May 24, 2017

NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08…

FDA Devices Critical May 24, 2017

NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T,…

FDA Devices Moderate Feb 22, 2017

StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

FDA Devices Critical Mar 16, 2016

MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 0871764…

FDA Devices Moderate Feb 6, 2013

Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 101165…

FDA Devices Moderate Oct 3, 2012

Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Abbott Vascular with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.