PlainRecalls

Abbott Vascular

21 recalls on record · Latest: Oct 26, 2022

Abbott Vascular Recall Insight

Abbott Vascular appears on 21 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.025% 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 21 entries, severity tagging shows 12 critical, 9 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 21 of 21 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 (21). 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 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 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 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 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 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 Oct 3, 2012

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

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Data Sources

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