ConcertoTM PV-8-30-3D (UDI 00847536026445)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536026445), received between Aug 20, 2021 and Aug 20, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT BEGAN EXPERIENCING SYMPTOMS TWO WEEKS AFTER BEING IMPLANTED WITH CONCERTO COILS. THEY INITIALLY EXPERIENCED NEEDLES AND PINS IN THEIR FEET AND SEVERE PAINS, SWELLING AND REDNESS IN DIFFERENT AREAS OF THEIR BODY. THEIR QUALITY OF LIFE WAS SEVERELY IMPACTED. THEY UNDERWENT MULTIPLE DIFFERENT TEST TO IDENTIFY REASONS FOR THIS PROBLEM AND AFTER 2 YEARS THEY SAID THE COILS MIGHT BE CAUSING AN ALLERGIC REACTION. THERE WERE NO MALFUNCTIONS WITH THE DEVICE, AND THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR VARICOCELE. ADDITIONAL INFORMATION RECEIVED REPORTED ALLERGY TO THE CONCERTO COILS WAS ONLY CONSIDERED AFTER 2 YEARS OF TESTING. THE PATIENT UNDERWENT SEVERAL SCANS, ARTHRITIC TREATMENTS, AND ALLERGY TESTS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW SEVERAL DOCTOR AND WAS HOSPITALIZED TO ADDRESS THE PAIN RELATED TO THE EVENT. THE EVENTS WERE NOT CONSIDERED LIFE-THREATENING BUT WERE NOTED TO BE DETRIMENTAL TO THE PATIENT'S QUALITY OF LIFE. THE PATIENT CONTINUES TO HAVE SYMPTOMS.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Paresthesia; Swelling/ Edema

  MAUDE report 12348870 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT BEGAN EXPERIENCING SYMPTOMS TWO WEEKS AFTER BEING IMPLANTED WITH CONCERTO COILS. THEY INITIALLY EXPERIENCED NEEDLES AND PINS IN THEIR FEET AND SEVERE PAINS, SWELLING AND REDNESS IN DIFFERENT AREAS OF THEIR BODY. THEIR QUALITY OF LIFE WAS SEVERELY IMPACTED. THEY UNDERWENT MULTIPLE DIFFERENT TEST TO IDENTIFY REASONS FOR THIS PROBLEM AND AFTER 2 YEARS THEY SAID THE COILS MIGHT BE CAUSING AN ALLERGIC REACTION. THERE WERE NO MALFUNCTIONS WITH THE DEVICE, AND THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR VARICOCELE. ADDITIONAL INFORMATION RECEIVED REPORTED ALLERGY TO THE CONCERTO COILS WAS ONLY CONSIDERED AFTER 2 YEARS OF TESTING. THE PATIENT UNDERWENT SEVERAL SCANS, ARTHRITIC TREATMENTS, AND ALLERGY TESTS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW SEVERAL DOCTOR AND WAS HOSPITALIZED TO ADDRESS THE PAIN RELATED TO THE EVENT. THE EVENTS WERE NOT CONSIDERED LIFE-THREATENING BUT WERE NOTED TO BE DETRIMENTAL TO THE PATIENT'S QUALITY OF LIFE. THE PATIENT CONTINUES TO HAVE SYMPTOMS. REFER TO MANUFACTURER REPORT 2029214-2021-01043 FOR DETAILS PERTAINING TO THE RELATED RE

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Paresthesia; Swelling/ Edema

  MAUDE report 12348807 ↗