Recall archive
15 recalls · page 1 of 1
Reported Jan 1, 2025
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular Inc.
Matched: Brand — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand — An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
Matched: Brand — There is a potential that the proximal marker may separate from the imaging catheter
FDA (openFDA device enforcement)
Reported Apr 20, 2022
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand — Due to an increase in complaint trend for leaks and intermittent/loose connections.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand — Incorrect expiration date
FDA (openFDA device enforcement)
Reported 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…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
Matched: Brand — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2019
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand · Product · Product details — Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force…
FDA (openFDA device enforcement)
Reported Mar 6, 2019
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand · Product · Product details — Incorrect expiration being entered for one lot.
FDA (openFDA device enforcement)
Reported Jun 7, 2017
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
Matched: Brand · Product · Product details · Reason for recall — Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major…
FDA (openFDA device enforcement)
Reported May 24, 2017
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
Matched: Brand — Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2017
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand · Product · Product details · Reason for recall — Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
FDA (openFDA device enforcement)
Reported Mar 16, 2016
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Vascular
Matched: Brand · Reason for recall — Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted…
FDA (openFDA device enforcement)
Reported Jan 1, 2014
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular, Inc.
Matched: Brand · Reason for recall — Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of…
FDA (openFDA device enforcement)
Reported Feb 6, 2013
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand · Reason for recall — The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit…
FDA (openFDA device enforcement)
Reported Oct 3, 2012
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
Matched: Brand · Product · Product details · Reason for recall — Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty…
FDA (openFDA device enforcement)
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