ConcertoTM PV-14-40-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · PV-14-40-HELIX CONCERTO PGLA COIL · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536017047), received between Jan 3, 2019 and Jan 3, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2019Migration; Migration
MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL THAT MIGRATED POST PROCEDURE TO THE AXILAR ARTERY AFTER BEING IMPLANTED IN THE CORRECT LOCATION. THE ISSUE WAS NOTICED THE DAY AFTER PROCEDURE AND RESULTED IN PATIENT INJURY. IT IS UNKNOWN WHAT THE CAUSE OF MIGRATION WAS. THE PATIENT UNDERWENT COILING EMBOLIZATION OF OCCLUSION OF LEFT SUBCLAVIA ARTERY. THE VESSEL WAS NORMAL TORTUOUS AND BLOOD FLOW WAS LOW. IT WAS REPORTED THAT THE CONCERTO COIL WAS IMPLANTED AT INTENDED LOCATION. AFTER THE IMPLANTATION OF A TORACICA ENDOPROTESIS. THE COIL IN THE CONTROL IS PLACED IN THE RIGHT PLACE AND IN GOOD CONDITION. THE DURING DAY CHECK THE ARM AND OBSERVE THE MIGRATED COIL TO THE AXILLAR ARTERY. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. YES, THE EVENT LEAD O PATIENT HOSPITALIZATION. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. ACCESSORY DEVICES WILL NOT BE RETURNED AS HOSPITAL DOSE NOT ALLOW. ANCILLARY DEVICES INCLUDE AN INTRODUCTOR DIAGNOSTICO 7 FR, CATHETER MULTIPROPOSITO 5FR.
Patient problems: Foreign Body In Patient
MAUDE report 8214271 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page