RotaLink™ Plus H749236310060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729228394), received between Apr 4, 2017 and Nov 24, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 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.

• MalfunctionNov 24, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A SEVERELY CALCIFIED LESION. THIS 2.25MM ROTABLATOR PLUS ALONG WITH A ROTAWIRE DRIVE WERE SELECTED. DURING THE PROCEDURE, THE ROTALINK PLUS BURR AND ROTAWIRE DRIVE BECAME LOCKED UP AND COULD NOT BE REMOVED. THEREFORE THE ROTALINK PLUS AND ROTAWIRE DRIVE WERE REMOVED FROM THE PATIENT AS ONE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868434 ↗
• MalfunctionMar 1, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BURR WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN- LEFT ANTERIOR DESCENDING ARTERY. A 2.25MM ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. UPON REMOVAL OF BOTH DEVICES, A KINK ON THE WIRE WAS NOTED AND BURR WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393647 ↗
• MalfunctionApr 23, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 2.25MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE ROTATIONAL SPEED WAS UNSTABLE; SET OPERATIONAL SPEED WAS 190000 RPM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990316 ↗
• MalfunctionMar 15, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A BRAKE MALFUNCTION OCCURRED. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.25MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BRAKE DEFEAT BUTTON OF THE ROTABLATOR WAS NOT PRESSED; HOWEVER, THE WIRE CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424611 ↗
• MalfunctionFeb 11, 2019Unstable; Output Problem; Unstable; Output Problem

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.25MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE SPEED WAS SET AT 180,000RPM, THE SET UP WAS COMPETED. DURING THE PROCEDURE, AT THIRD ABLATION, IT WAS NOTED THAT THE ROTATION SPEED DID NOT INCREASE. THE SETTING WAS CHECKED AGAIN OUTSIDE THE PATIENT, AND THE SPEED WAS NOTED TO BE UNSTABLE INCREASING AND DECREASING. IT FURTHER DID NOT INCREASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325621 ↗
• MalfunctionJul 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRIVE SHAFT SHEATH WAS TORN. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.25MM ROTA LINK¿ PLUS WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE ROTATION SPEED WAS ADJUSTED OUTSIDE PATIENT'S BODY, IT WAS NOTED THAT THE ROTATION SPEED DID NOT INCREASE AND ABNORMAL SOUND WAS HEARD FROM THE ADVANCER AND THE CONSOLE. AFTER CHECKING THE STATUS AGAIN, THE ROTABURR ROTATED NORMALLY OUTSIDE THE PATIENT'S BODY. HOWEVER, WHEN THE ROTATION SPEED WAS ADJUSTED AGAIN, IT DID NOT INCREASE IN THE SAME WAY AND ABNORMAL SOUND WAS HEARD. FURTHERMORE, THE DRIVE SHAFT SHEATH PORTION WAS CHECKED AND WAS FOUND TORN OR SEPARATED. CONSEQUENTLY, USAGE OF THE ROTABURR WAS STOPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703889 ↗
• MalfunctionJun 26, 2018Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2018-05723. IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, SEVERELY CALCIFIED AND 3.7MM IN DIAMETER PROXIMAL RIGHT CORONARY ARTERY. A ROTAWIRE¿ AND A 2.25MM ROTALINK¿ PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, A 1.75MM BURR WAS INITIALLY USED DUE TO THE HIGH STENOSIS RATE AND SEVERE CALCIFICATION. WHEN THE VESSEL DIAMETER WAS MEASURED BY IVUS, THE SIZE WAS 3.7MM; THUS THE BURR WAS EXCHANGED WITH A BIGGER SIZE OF 2.25MM. WHEN THE 2.25MM ROTABURR WAS INSERTED INTO A NON-BSC GUIDE CATHETER, SEVERE RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE BURR THROUGH DYNAGLIDE MODE; HOWEVER, IT WAS OBSERVED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH A 2.15MM ROTABURR AND ANOTHER OF THE SAME ROTAWIRE TO ENSURE PATIENT SAFETY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638248 ↗
• MalfunctionMay 31, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ROTAWIRE WAS MOVING TOGETHER WITH THE BURR. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.25MM ROTALINK¿ PLUS WAS SELECTED FOR USE. DURING PROCEDURE, AFTER THE FIRST ABLATION, IT WAS NOTED THAT THE ROTAWIRE MOVED TOGETHER WITH THE BURR. BOTH DEVICES WERE REMOVED AS A SYSTEM AND A NEW ROTAWIRE WAS THEN ADVANCED. IT WAS OBSERVED THAT THE SAME ISSUE OCCURRED. THE ROTALINK PLUS WAS CONSEQUENTLY REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557595 ↗
• MalfunctionApr 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.25MM ROTALINK¿ PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTATION SPEED OF THE DEVICE WAS UNSTABLE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7408709 ↗
• MalfunctionApr 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ROTATIONAL SPEED WAS UNSTABLE. A 2.25MM ROTALINK¿ PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE ROTATION SPEED WAS NOT STABLE. NO PATIENT COMPLICATIONS AND PATIENT INJURY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7407282 ↗
• MalfunctionApr 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A 2.25MM ROTALINK¿ PLUS WAS SELECTED FOR USE. AFTER SETTING UP THE DEVICE, THE SPEED WAS SET TO 200KPM OUTSIDE THE PATIENT. THEN, THE PHYSICIAN TRIED TO DELIVER USING DYNAGLIDE MODE FROM THE GUIDING CATHETER. HOWEVER, THE ROTATION SPEED DID NOT STABILIZED AND WAS NOT DELIVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456388 ↗

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-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• 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
• 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