Stent, Coronary
FDA adverse event reports and recall history for stent, coronary (product code MAF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 23,275
- Deaths
- 1,758
- Injuries
- 11,932
- Malfunctions
- 9,400
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-10-21TerminatedLabeling design
Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.
Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte Bare-Metal stent, and Libert Bare-Metal stents have been ina
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-02-03TerminatedPackage design/selection
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the
- 2007-08-29TerminatedOther
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
- 2005-05-18TerminatedOther
Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)
Potential for deployment difficulties.
- 2005-04-13TerminatedOther
Voyager RX Coronary Dilatation Catheter
Leak at guide wire exit notch could introduce air into the artery.
- 2004-07-27TerminatedOther
Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.
Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
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