Catheter, Coronary, Atherectomy

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

• 2019-12-19TerminatedReprocessing Controls

  AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.

  Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.

• 2015-11-13TerminatedComponent change control

  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.

  Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

• 2015-11-13TerminatedComponent change control

  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.

  Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

• 2015-03-20TerminatedNonconforming Material/Component

  Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

  The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.

• 2014-02-26TerminatedProcess control

  CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

  Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C

• 2007-06-21TerminatedOther

  Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).

  Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

• 2007-06-14TerminatedOther

  St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.

  Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.

• 2006-01-31TerminatedOther

  The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLlPIT1M clips are provided to aid in handling of the catheter.

  The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

• TerminatedEmployee error

  Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

  Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

• Open, ClassifiedProcess control

  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

  Pouch seals may be open, compromising sterility.