ConcertoTM PV-6-20-3D (UDI 00847536033788)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536033788), received between Jan 5, 2022 and Nov 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AT THE TIME OF MANUAL RELEASE OF THE COIL, THE BLACK INDICATOR/MARK OF THE INPUT WAS CUT/BROKEN AND THE THREAD OF THE COIL WAS NOT VISIBLE/DID NOT APPEAR TO DISASSEMBLE IT. THE COIL REMAINED INSIDE THE CATHETER WITHOUT DIFFICULTY IN REMOVING THE COIL BUT THE MEDICAL TEAM NO LONGER HAD A WAY TO POSITION OR DEPLOY IT. IT WAS DECIDED TO REMOVE THE ENTIRE WIRE. THE DEVICE HAD BEEN INSPECTED WITH NO ISSUES NOTED. A BREAK WAS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A DISTAL ARTERY. THE DEGREE OF TORTUOSITY WAS LITTLE. THERE WAS NO DEGREE OF CALCIFICATION AND NO STENOSIS. ARTERY DIAMETER WAS 3-4MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570371 ↗
• InjuryJun 17, 2024Migration; Physical Resistance/Sticking; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL MIGRATED AND AN ECHELON HAD DIFFICULT NAVIGATION. 1ST DID LEFT SUPERIOR VENA CAV A (SVC) ¿ VERY TORTUOUS USED ECHELON COULDN¿T GET 4FR GUIDE CATH. SO COULDN¿T PUT A PLUG, SO COILED WITH A 3D 6X20. THINKS IT MAY HAVE BEEN OVERSIZED BECAUSE IT DIDN¿T PACK WELL. PROXIMAL TORTUOSITY. GRABBED MICRO AND WAS GOING TO PUT IN A 2ND COIL BUT WHEN MICRO TOUCHED IT THE COIL MOVED DISTALLY, TO A SEGMENT THAT WAS IN A LARGER DIAMETER SEGMENT OF THE VESSEL. THE HEALTHCARE PROVIDER (HCP) WAS CONSIDERING SNARING IT AND GOT A 2ND OPINION. THE COIL APPEARED TO BE IN A STABLE POSITION, SO THEY DIDN¿T SNARE IT. THEN EMBOLIZED VERY PROXIMALLY WITH A 5X15 3D. IT MOVED TO THE RIGHT SIDE.  DID THE MVPS AND STENT AND FINISHED THE CASE AND IT REMAINED STABLE. SOMEONE CAME IN AND SWITCHED HIS G TUBE TO A J TUBE AND THEY DID 3 FLUOROS AND THE COIL HADN¿T MOVED. THE G TUBE WAS VERY CLOSE TO THE COIL. NEXT DAY THE COIL WASN¿T WHERE THEY LAST SAW IT. AFTER LOOKING FOR IT, THEY FOUND IT HAD EMBOLIZED TO LEFT INTERNAL CAROTID. TOOK HIM TO NEUROSURGERY. CEREBRAL ANGIO. CRANIOTOMY. DISSECTED TO LEFT MIDDLE CEREBRAL ARTERY. DUEL ANTI PLATELET THERAPY. HAD A STROKE ON

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Ischemia Stroke

  MAUDE report 19554920 ↗
• MalfunctionSep 15, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DEPLOY FROM THE DELIVERY DEVICE. OBLIGATION TO TAKE A NEW DEVICE. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435050 ↗
• MalfunctionAug 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL WAS JAMMED IN THE SHEATH. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201355 ↗
• MalfunctionJan 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE COIL WAS STUCK IN THE SHEATH, SO IT WAS REPLACED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS UNDERGOING GASTRODUODENAL ARTERY EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DAMAGE SEEN TO THE COIL OR CATHETER. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A MAESTRO 2.8F MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173488 ↗