Manufacturer

Abbott Vascular

37 recalls in our database name Abbott Vascular as the manufacturing or recalling firm.

What the numbers show

Total: 37
Critical: 5
Severe: 14
Most recent: 2022-10-26

Of the 37 recalls from Abbott Vascular we have scored against our rubric, 5 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (38%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–37 of 37

HighFDA (Devices)·Z-1132-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
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 for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1143-2020·2020-02-26
Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
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 cleared for commercial distribution in the United States.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1687-2019·2019-06-05
Abbott MitraClip XTR Clip Delivery System Recalled for Malfunction
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Product
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-0960-2019·2019-03-06
Abbott Vascular Recalls PLUS 30 Priority Pack Accessory Kit Due to Expiration Error
Abbott Vascular is recalling 26 units of the PLUS 30 Priority Pack Accessory Kit because an incorrect expiration date was entered for one lot.
Product
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devic
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2151-2017·2017-06-07
Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates
Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.
Product
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disea
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2038-2017·2017-05-24
Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues
Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Product
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2037-2017·2017-05-24
Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues
Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Product
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2039-2017·2017-05-24
Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues
Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Product
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1202-2017·2017-02-22
Abbott StarClose SE Vascular Closure System Recall for Deployment Failure
Abbott Vascular is recalling the StarClose SE Vascular Closure System because the device may fail to deploy the clip.
Product
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0911-2016·2016-03-16
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Mandrel Fracture
Abbott Vascular is recalling the MitraClip Clip Delivery System because a mandrel fracture may prevent the clip from detaching during implantation.
Product
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0757-2013·2013-02-06
Abbott Vascular Recalls RX Accunet Embolic Protection System Lots
Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System because the peel-away sheath may be difficult to remove due to higher than normal wall thickness.
Product
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2450-2012·2012-10-03
Abbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues
Abbott Vascular is recalling Armada 35 and Armada 35 LL PTA Catheters because some devices may have difficulty inflating or deflating.
Product
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Abbott Vascular (United States)

company in Santa Clara, United States

Country: United States

Official website

Source: Wikidata (Q124251948), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.