RotaLink™ Burr H802227680050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729126881), received between Jan 17, 2017 and Dec 19, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (P900056); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS STUCK. THE 85% STENOSED, 60MM X 3.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TIP OF THE BURR WAS STUCK AND THE DEVICE WAS REMOVED TOGETHER WITH THE WHOLE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982819 ↗
• MalfunctionAug 22, 2024Gas/Air Leak; Gas/Air Leak

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JUL2024. IT WAS REPORTED THAT AIR LEAKAGE OCCURRED BETWEEN THE BURR AND THE ADVANCER. A 2.00MM ROTALINK BURR WAS SELECTED FOR USE IN THE CALCIFICATION OF THE RIGHT CROWN. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS AIR LEAKAGE BETWEEN THE BURR AND THE ADVANCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS SEPARATION OF THE SHEATH AT THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024388 ↗
• MalfunctionApr 26, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25APR2023. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE 60MMX2.5MM, 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS BROKEN AT THE DISTAL END OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815105 ↗
• MalfunctionMar 8, 2023Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR WAS STUCK IN LESION. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR STUCK IN THE LESION AND THE SPEED DROPPED SIGNIFICANTLY. A GUIDEZILLA II WAS USED AGAINST THE LESION TO REMOVE THE ENTIRE SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504470 ↗
• MalfunctionApr 28, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A 2.00MM ROTALINK BURR AND A 330CM ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED WHEN USED ALONG WITH 2.00MM ROTALINK BURR. ACCORDING TO THE PHYSICIAN, THE FRACTURE WAS DUE TO THE LESION CHARACTERISTICS. THE DEVICE WAS COMPLETELY REMOVED VIA NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14245112 ↗
• InjuryJun 2, 2021Difficult to Remove; Output Problem; Difficult to Remove; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK INSIDE A PLACED STENT. THE TARGET LESION WAS LOCATED IN 95% STENOSED, MODERATELY TORTUOUS, HEAVILY CALCIFIED IN-STENT RESTENOSIS WITH A STENT LENGTH WHICH PRESUMED TO BE 60MM+ WITH DIFFUSE OF THE RIGHT CORONARY ARTERY. DURING PROCEDURE, A 1.75MM ROTABURR WAS ADVANCED AND ROTABLATED THROUGH THE DISEASE. THEN, BALLOONING WITH NC BALLOONS WAS PERFORMED; HOWEVER, WAISTING OF THE BALLOONS WAS VISIBLE DUE TO REMAINING CALCIUM. IT WAS NOTED THE NON-COMPLIANT BALLOONS WERE INFLATED AT HIGH PRESSURE, HOWEVER THE FORCE OF THE BALLOON WAS NOT ENOUGH TO EXPAND THE CALCIUM CAUSING A WAISTING AFFECT SEEN ON THE BALLOON. A 2.00MM ROTALINK BURR WAS THEN SELECTED FOR USE. ON ADVANCEMENT OF THE 2.00MM ROTABURR, THE SPEED DECELERATED, STALLED AND BURR WAS STUCK WITHIN THE CAGE OF THE EXISTING STENT. MULTIPLE REMOVAL TECHNIQUES WERE ATTEMPTED; HOWEVER THE PATIENT HAD TO BE TRANSFERRED TO A CARDIOTHORACIC CENTER FOR SURGICAL REMOVAL OF THE BURR. CONSEQUENTLY, THE BURR WAS UNABLE TO BE REMOVED, AND THE SHAFT OF THE BURR WAS CUT PROXIMAL TO THE STENT. A SURGICALLY IMPLANTED BY-PASS GRAFT WAS INSERTED TO DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN NOTED THAT PATI

  Patient problems: Foreign Body In Patient

  MAUDE report 11922572 ↗
• MalfunctionMar 15, 2021Entrapment of Device; Noise, Audible; Entrapment of Device; Noise, Audible

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 2.00MM ROTALINK BURR, A ROTALINK ADVANCER, AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION TO TREAT CORONARY ARTERY DISEASE. AFTER WIRING THE VESSEL WITH A CONVENTIONAL WORKHORSE WIRE AND THEN EXCHANGING FOR A ROTAWIRE, A ROTALINK BURR WAS ADVANCED INTO THE PROXIMAL RIGHT CORONARY ARTERY USING DYNAGLIDE MODE. BEFORE ABLATION BEGAN IN THE TARGET LESION, AN UNUSUAL CONSTANT NOISE WAS HEARD FROM THE CONSOLE. THE PHYSICIAN WAS UNDER THE IMPRESSION THAT THE BURR WAS NOT ROTATING. SINCE THE CAUSE OF THE PROBLEM COULD NOT BE IDENTIFIED, THE ROTALINK BURR WAS REMOVED, BUT IT WAS STUCK ON THE ROTAWIRE. WHEN WITHDRAWING THE ROTALINK BURR, THE ROTAWIRE CAME BACK AS WELL DESPITE BEING SECURED WITH THE BRAKE. ULTIMATELY, THE ROTALINK BURR, THE ROTALINK ADVANCER, AND THE ROTAWIRE WERE ALL EXCHANGED FOR NEW DEVICES OF THE SAME TYPE. THE ROTAWIRE WAS NOTED AS NOT KINKED, INITIALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER CLARIFIED THAT THERE WAS NO ISSUE WITH THE GUIDEWIRE BRAKE, AND THE ROTAWIRE WAS NOT KINKED. WHEN ATTEMPTING TO REMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483459 ↗
• InjuryMay 11, 2020Device Damaged by Another Device; Output Problem; Device Damaged by Another Device; Output Problem

  IT WAS REPORTED THAT THE WIRE FRACTURED AND THE PATIENT EXPERIENCED A PERFORATION, INTRAMURAL HEMATOMA AND CHEST DISCOMFORT. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL-MID RIGHT CORONARY ARTERY (RCA). A 1.5MM ROTALINK BURR, 2.00MM ROTALINK BURR AND A 330CM ROTAWIRE WERE SELECTED FOR USED. DURING THE PROCEDURE, THE BURR WAS CHANGED UP TO 2.00MM AFTER ABLATION INITIALLY BEGUN WITH A 1.5MM BURR. DURING ABLATION, THE 2.00MM BURR STALLED AND THE ROTAWIRE FRACTURED. THE FRACTURED WIRE LODGED INTO THE POSTERIOR LEFT VENTRICULAR (PLV) AND THERE WAS PERFORATION AND INTRAMURAL HEMATOMA IN THE RCA. THE WIRE WAS ABLE TO BE REMOVED. TWO STENTS WERE DEPLOYED INTO THE LESION WHICH SEALED THE PERFORATION. IVUS SHOWED GOOD SEAL, NO SIGNIFICANT EFFUSION ON BEDSIDE TRANSTHORACIC ECHOCARDIOGRAM (TTE). CLINICAL DECISION WAS MADE TO NOT PROCEED TO STENT THE LEFT ANTERIOR DESCENDING ARTERY. FELODIPINE WAS COMMENCED TO REDUCE CORONARY SPASM AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT ENDURED MILD CONSTANT CHEST DISCOMFORT, DIFFERENT FROM PRESENTING ANGINA. IT WAS WORSE WITH DEEP INSPIRATION AND WAS CONSISTENT WITH INFLAMMATORY PERICARDITIC E

  Patient problems: Chest Pain; Hematoma; Perforation; Pericardial Effusion; Vasoconstriction

  MAUDE report 10042838 ↗
• MalfunctionDec 9, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILITY WAS COMPROMISED AS THE INNER PACKAGE OF THE DEVICE WAS DAMAGED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM ROTALINK BURR WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE STERILITY WAS COMPROMISED AS THE INNER PACKAGE OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9439444 ↗
• MalfunctionMay 31, 2019Fracture; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Fracture; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ROTAWIRE FRACTURE OCCURRED. A 330CM ROTAWIRE WAS BEING USED WITH A 1.5MM ROTALINK BURR. ABLATION WAS SUCCESSFUL. THE PHYSICIAN THEN EXCHANGED THE 1.5MM BURR WITH A 2.0MM ROTALINK. THE 2.0MM ROTALINK BURR ADVANCED OVER THE SAME 330CM ROTAWIRE WITHOUT FRICTION. ROTATIONAL TESTING WAS PERFORMED OUTSIDE OF THE PATIENT AT 180,000 RPM WHICH RESULTED IN THE 330CM ROTAWIRE BECOMING FRACTURED. THE DEVICES WERE EXCHANGED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL AND STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658299 ↗
• MalfunctionJan 17, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS 2134265-2016-12669. IT WAS REPORTED THAT THE BURR BECAME STUCK IN LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING THE USE OF A 2.00MM ROTALINK¿ BURR, THE BURR GOT STUCK IN THE LESION. THE BURR WAS THEN TUGGED AND REMOVED FOR THE PATIENT'S BODY. A 2.75 X 12 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS THEN DEPLOYED WITH EXCELLENT RESULT. NO PATIENT COMPLICATIONS WERE REPORTED. LATER THAT EVENING THE PATIENT EXPERIENCED CHEST PAIN AND HAD DEVELOPED THROMBOSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6256597 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator